procedimiento estudios fase iv unidad cardiovascular novartis argentina sergio volman agosto 2008...
TRANSCRIPT
PROCEDIMIENTO ESTUDIOS FASE IV
Unidad Cardiovascular
Novartis Argentina
Sergio Volman
Agosto 2008
ISPOR
Introduccioacuten
Enorme incremento de costo alocados en Investigacioacuten cliacutenica
Menor nuacutemero de drogas aprovadas
El costo de una nueva moleacutecula desde su descubrimiento hasta su comercializacioacuten es US$ 11 Tiempo 10-12 antildeos
No garantiza su eacutexito
Tiempo de patentes es menor dado que hay mayor desarrollo en investigacioacuten y menor en comercializacioacuten
Las empresas requieren altos MS en forma precoz
Autoridades Regulatorias
Exigen mayores evidencias acerca del perfil de seguridad de las drogas
Asegurar riesgo beneficio de la moleacutecula
Exigen la realizacioacuten de PMS Risk Management como soporte para su ingreso al mercado
4 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Sources of ldquoReal World Datardquo
EBM amp RCT placed at the top of the evidence hierarchy
bull Limited controlled experiment that not generalize to population settings or conditions not reflected in the trial
bull Impracticality of basing all of medicine on RCTs
bull Expensive
ISPOR ldquoReal Worldrdquo Task Force Report
bull Supplements to traditional registriation RCTs
bull Large simple trials (practical clinical trials)
bull Registries
bull Administrative data
bull Health surveys
bull Electronic records and medical chart reviews
bull httpwwwjusgovardatospersonales
bull httpwwwhc-virtualcom
5 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Ensayos Cliacutenicos Fase IV
1048698SujetosMaacutes de mil pacientes (Condiciones reales de uso)
1048698 ObjetivoSeguridad en condiciones reales de uso en poblaciones con
gran nuacutemero de sujetos
1048698 Informacioacuten que podemos obtenerOtros datos de eficacia
Datos de faacutermaco-economiacutea
Farmacovigilancia
Seguridad tras el empleo prolongado yo en grandes grupos
Deteccioacuten de efectos indeseables de baja yo muy baja frecuencia
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Introduccioacuten
Enorme incremento de costo alocados en Investigacioacuten cliacutenica
Menor nuacutemero de drogas aprovadas
El costo de una nueva moleacutecula desde su descubrimiento hasta su comercializacioacuten es US$ 11 Tiempo 10-12 antildeos
No garantiza su eacutexito
Tiempo de patentes es menor dado que hay mayor desarrollo en investigacioacuten y menor en comercializacioacuten
Las empresas requieren altos MS en forma precoz
Autoridades Regulatorias
Exigen mayores evidencias acerca del perfil de seguridad de las drogas
Asegurar riesgo beneficio de la moleacutecula
Exigen la realizacioacuten de PMS Risk Management como soporte para su ingreso al mercado
4 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Sources of ldquoReal World Datardquo
EBM amp RCT placed at the top of the evidence hierarchy
bull Limited controlled experiment that not generalize to population settings or conditions not reflected in the trial
bull Impracticality of basing all of medicine on RCTs
bull Expensive
ISPOR ldquoReal Worldrdquo Task Force Report
bull Supplements to traditional registriation RCTs
bull Large simple trials (practical clinical trials)
bull Registries
bull Administrative data
bull Health surveys
bull Electronic records and medical chart reviews
bull httpwwwjusgovardatospersonales
bull httpwwwhc-virtualcom
5 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Ensayos Cliacutenicos Fase IV
1048698SujetosMaacutes de mil pacientes (Condiciones reales de uso)
1048698 ObjetivoSeguridad en condiciones reales de uso en poblaciones con
gran nuacutemero de sujetos
1048698 Informacioacuten que podemos obtenerOtros datos de eficacia
Datos de faacutermaco-economiacutea
Farmacovigilancia
Seguridad tras el empleo prolongado yo en grandes grupos
Deteccioacuten de efectos indeseables de baja yo muy baja frecuencia
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Autoridades Regulatorias
Exigen mayores evidencias acerca del perfil de seguridad de las drogas
Asegurar riesgo beneficio de la moleacutecula
Exigen la realizacioacuten de PMS Risk Management como soporte para su ingreso al mercado
4 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Sources of ldquoReal World Datardquo
EBM amp RCT placed at the top of the evidence hierarchy
bull Limited controlled experiment that not generalize to population settings or conditions not reflected in the trial
bull Impracticality of basing all of medicine on RCTs
bull Expensive
ISPOR ldquoReal Worldrdquo Task Force Report
bull Supplements to traditional registriation RCTs
bull Large simple trials (practical clinical trials)
bull Registries
bull Administrative data
bull Health surveys
bull Electronic records and medical chart reviews
bull httpwwwjusgovardatospersonales
bull httpwwwhc-virtualcom
5 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Ensayos Cliacutenicos Fase IV
1048698SujetosMaacutes de mil pacientes (Condiciones reales de uso)
1048698 ObjetivoSeguridad en condiciones reales de uso en poblaciones con
gran nuacutemero de sujetos
1048698 Informacioacuten que podemos obtenerOtros datos de eficacia
Datos de faacutermaco-economiacutea
Farmacovigilancia
Seguridad tras el empleo prolongado yo en grandes grupos
Deteccioacuten de efectos indeseables de baja yo muy baja frecuencia
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
4 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Sources of ldquoReal World Datardquo
EBM amp RCT placed at the top of the evidence hierarchy
bull Limited controlled experiment that not generalize to population settings or conditions not reflected in the trial
bull Impracticality of basing all of medicine on RCTs
bull Expensive
ISPOR ldquoReal Worldrdquo Task Force Report
bull Supplements to traditional registriation RCTs
bull Large simple trials (practical clinical trials)
bull Registries
bull Administrative data
bull Health surveys
bull Electronic records and medical chart reviews
bull httpwwwjusgovardatospersonales
bull httpwwwhc-virtualcom
5 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Ensayos Cliacutenicos Fase IV
1048698SujetosMaacutes de mil pacientes (Condiciones reales de uso)
1048698 ObjetivoSeguridad en condiciones reales de uso en poblaciones con
gran nuacutemero de sujetos
1048698 Informacioacuten que podemos obtenerOtros datos de eficacia
Datos de faacutermaco-economiacutea
Farmacovigilancia
Seguridad tras el empleo prolongado yo en grandes grupos
Deteccioacuten de efectos indeseables de baja yo muy baja frecuencia
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
5 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Ensayos Cliacutenicos Fase IV
1048698SujetosMaacutes de mil pacientes (Condiciones reales de uso)
1048698 ObjetivoSeguridad en condiciones reales de uso en poblaciones con
gran nuacutemero de sujetos
1048698 Informacioacuten que podemos obtenerOtros datos de eficacia
Datos de faacutermaco-economiacutea
Farmacovigilancia
Seguridad tras el empleo prolongado yo en grandes grupos
Deteccioacuten de efectos indeseables de baja yo muy baja frecuencia
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
6 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Poner de manifiesto sus efectos farmacodinaacutemicos recoger datos referentes a su absorcioacuten distribucioacuten metabolismo y excrecioacuten
Establecer su eficacia para una indicacioacuten terapeacuteutica profilaacutectica o diagnoacutestica
Conocer el perfil de sus reacciones adversas y establecer su seguridad
Reunir la suficiente informacioacuten documental que demuestre el adecuado balance beneficio-riesgo que la informacioacuten se ha obtenido de una forma eacutetica y metodoloacutegicamente adecuada y siguiendo la normativa vigente
Objetivo del Ensayo Cliacutenico
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Definicioacuten PH IV study
ldquoSe define a los estudios de Fase IV como estudios cliacutenicos intervencionistas con un producto dentro de una indicacioacuten dosisesquema de dosificacioacuten aprobada para su publicacioacuten o bien para la exploracioacuten de nuevos usos siempre y cuando no haya intencioacuten de someter un nuevo registro
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Clasificacioacuten de Estudios Cliacutenicos seguacuten su financiacioacuten
Tipo a Pagados por Casa Matriz a traveacutes de reembolsos Los pagos hechos para los estudios de este tipo no deben afectar los resultados internos
Tipo b Pagados de forma compartida por Casa Matriz y con recursos propios del paiacutes
Tipo c Todos los gastos generados por el estudio son pagados con recursos locales El Asesor Meacutedico en coordinacioacuten con Marketing elabora el presupuesto del estudio sobre la base de los gastos proyectados
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Features Design Key Features
RCT (explanatiry)
Prospective Interventional
Gold Standard randomised blinded placebo-controlled to measure efficacy in highly selected patients with standardised and intense follow up
RCT (pragmaty)
Randomised open-label with a usual care control group to measure effectiveness in a broard patient population with follow up and less stringent inclusionexclusion criterion
Observational
Prospective observational
Non-randomised non interventional study that monitors a cohort(s) over time with possible inclusion of scheduled patient visit
Registry
Observational study of patients with a specific disease or receiving a specific treatment Described as peering over the shoulder of physicians and collecting data
Database analysis Chart review Model Retrospective
Captures patient data from an existing database
Captures patient data from patient records
Decisioacuten analytic framework that simulates the impact of intervention using multiple data sources
Phase IV Group
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Important strategic questions to ask when selecting a post-
marketing study designbull What is the primary research question or primary endponit being evaluated pricing and reimbursement publication planning risk management pivotal data gap competitive positioning In other world who are the intended recipients of the study results Is the study focus registration or non-registration
bull Is the motivation for the study founded upon an important research question which may ultimately influence madical practice and benefit the patient
bull What studies have already been undertaken by competitors
bull What is the timeframe for relevance of the study results
bull What is the budget for the study
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study
design Methodological Questionsbull Are comparative data required If yes
consider interventional
bull Do the study results need to have a high level of internal validity If yes consider interventional
bull Is there a need to measure a small difference in outcomes If yes consider interventional
bull Is there a need for longer term data If yes choose observational
bull Do the study results need to be generalisable If yes consider observational
bull Is there a need to estimates of drug utilisation and healthcare resources in real world practice If yes consider observational
bull At the outcome of interest rare events If yes consider observational
bull Are real worldnaturalistic effectiveness or safety results needed If yes consider observational
Practical questionsbull Do the outcomes of interest need to be
collected directly from the patients (for example patient reported outcome If yes consider either interventional or observational
bull Are the study results needed quickly If yes consider either interventional or retrospective
bull Is it a challenge to randomise patients to therapy or placebo due to ethical or recruitment issues If yes consider either interventional or retrospective
bull Are these sufficient historical data available in healthcare databases or in patient charts If yes consider retrospective
bull Is the budget limited os is it not feasible to conduct a resource-intensive study If yes consider either observational or retrospective
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Ahora bien
bull Definimos disentildeo del estudio
bull Estrategia y metodologiacutea
bull Requerimientos regulatorios
bull Definir el nivel de intervencioacuten
Para estudios observacionalesEs una gran ambiguedad
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
ldquoLa gran ambiguumledadrdquo
bull La prescripcioacuten estaacute separada de la inclusioacuten en el estudio
bull Interrogatorios cuestionarios muestras de sangre Queacute son
bull Debe quedar en claro que es parte de la actividad diaria
bull Sin embargohelliphellip
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Convencioacuten de Oviedo 2005
ldquocualquier intervencioacutenrdquo realizada durante un estudio cliacutenico que altere el bienestar humano que comprometa fisicamente o ponga en riesgo la salud psicoloacutegica de un paciente
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
15 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
16 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Create momentum
Create Noise
Build a community
Position your product or service
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
17 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Turning the marketing wheel
Real worldUsage trends
Physicianrelationship
KOL relationship
Key physicianpresibers
Reimbursementsupport
Trade Publication
SymposiumPresentation
SalesRepresentatives
User meetingpresentation
Supplementssymposium
Peer review articules
New indication
Off Labelmonitoring
Support RMP
RegistriesPMSs PhIV Studies
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
18 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Conclusion
The true challenge in strategically designing post-marketing research is to appropiately blend scientific objetives with commercial objetives while maintaining regulatory compliance Scientific and commercial objetives can co-exist in the same atudy if designed well
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
19 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Otros ISSUES a resolver
Costos del estudio
Analizar adecuadamente la validez interna y externa
Necesidad de monitoreo Gran impacto presupuestario
Falta de definicioacuten HA acerca de procedimientos a cumplir en estudios observacionales en fase IV
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
20 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Diapo de Articulo PDF
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
Alguna pregunta
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
COMITEacute DE ESTUDIOS CLINICOS
ASESOR MEDICO GERENTE DE PRODUCTOStudy Concept Sheet + Business Rationale + Trial Commitment Form
DIRECTOR MEDICO SUB REGIONAL REGIONALDIRECTOR DE MARKETING REGIONAL-Aprobacioacuten-Aprobacioacuten Condicional-Negacioacuten
ASESOR MEDICO Luego de la aprobacioacuten Regional sigue seguacuten Procedimientos globales y procedimientos locales descritos
-NIP MME02001 Local Phase IIIbIVc Trials
DIRECTOR MEDICOGERENTE DE MARKETING
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
AMCTL Seleccioacuten final de centros a traveacutes de un CEC
AMCROCRA
Visita de seleccioacuten de los centros
AMCTL Abre centro de costos-
Completa Form GSDC
DMAMCTL Se revisa el protocolo final protocol summary IC y CRF
DMICRO MngAM
Alocan presupuesto para recursos humanos
Coordinador de Fase IV (si necesario)
Training a todos los involucrados
AMCTLCRO
Prepara paquete regulatorio para centros y comunica a DRARegulatorioICRO
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
AMCRAIMS Reunioacuten de investigadores
AMCRA Enviacutea solicitud al TPA ingreso a base de registros puacuteblicos (SDCF)
Actualizacioacuten perioacutedica en IMPACT
CROCRAAM
Seguimiento y monitoreo del estudio de acuerdo a los procedimientos globales y locales aplicables
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-
25 | Presentation Title | Presenter Name | Date | Subject | Business Use Only
Clarify some distinctions between registries andclinical trials
Clinical Trials Registries PMSs
An experimentObservational study
design it is a survey
Active intervemtiondoes not specify
treatments observational
Randomization Procedures Observe
Inclusion and exclusion criterias
few inclusion and exclusion criteria
few inclusion and exclusion criteria
Homogeneous group broad range of patientsbroad range of
patients
Adhere to a strict schedule of visits
Conduct protocol-specific tests and measurements
test and measurements a provider customarily uses Safety IMS
- Slide 9
- Important strategic questions to ask when selecting a post-marketing study design
- Interventional observational or retrospective Methodological and practical questions to ask when selecting a post-marketing study design
- Ahora bien
- ldquoLa gran ambiguumledadrdquo
- Convencioacuten de Oviedo 2005
-