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Unpublished Trials Are Now Posted In ClinicalTrials.gov.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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