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How Good Is “Evidence” From Clinical Studies Of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs?
O (Naci H.,Ioannidis P.A.,Annu.Rev.Pharmacol.Toxicol.,2015,55:169-189)
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SUJITA MISHRAPI/289
Contents
Future Aspects
Conclusions
Introduction
Clinical Trials
Problems & Solution
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Introduction
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Phases Of Clinical Trials
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Problems in the Design of Clinical Studies of Drug Effects
Insufficient Considerations Of Evidence
Use Of Weak Study Designs
Industry Sponsorship Of Research
Lack Of Head–to-Head Comparisons
Choice Of Patient Population
Choice Of Outcomes
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Insufficient Considerations of Evidence
Continuously Updated
Assessments
Published Reports May Not Cited
Focus On Consulting Reviews
Disproportionate research
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Use Of Weak Study Designs
NON-RANDOMIZEDDESIGNS
RANDOMIZED DESIGNS
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Industry Sponsorship Of Research
Most Clinical Drug Research Is Sponsored by Pharmaceutical Industry
Industry Sponsored Studies Favour the Products Funded by Other Sources
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Lack Of Head-to-Head Comparisons
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Choice Of Patient Populations
It Should be Done Very Carefully
Depends on Age,Sex,Weight etc.,
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Choice Of Outcomes
Predict the Real-World
Utility
It Includes Composites
OfMultiple
Outcomes
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Problems in the Reporting of Clinical Trials
PUBLICATION
BIAS REPORTING
PAUCITY OF EVIDENCE ON HARMS
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Publication
Generally Reported Positive Results
Unpublished Trials Are Now Posted In ClinicalTrials.gov.
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Bias Reporting
Selective Citation of Clinical Studies
Selective OutcomeReporting
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Problems in the Evidence and in the Formation of Recommendations from Studies of Drug
Effects
META ANALYSES
RELIABILITY OF CLINICAL PRACTICE GUIDELINES
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Solution of Clinical Trial’s Problems
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Potential Improvements
Study Registrations
Provision Of Raw Data
Solution of Clinical Trial’s Problems
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Sponsoring of Clinical Research by Nonconflicted Entities
Requirement of Comparative Data at the Time of Drug Approvals
Nonconflicted Conduct Of Systematic Reviews
Future Aspects
ENSURE TRANSPARENCY
MEANINGFUL AND ACCURATE
EVIDENCE
DEVELOP TRANSFORMATIVE
IDEAS
ENHANCE PUBLIC TRUST
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Conclusions
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Cite existing or Prior reviews first
Clinical Agendas are Mostly in Favor with
Industry
Tackle the Numerous Defects in Clinical
Trials
Scientific Scrutiny Before Implemented
Acknowledgments
O I wish to acknowledge to-O Dr.SACHCHIDANAND SIR,O Dr.M.CHOURASIA SIR,O Dr.SHAILENDRA SIR,O SOHNI MAM, andO MY CLASSMATES.O I THANK YOU ALL……
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