This document discusses problems with evidence from clinical drug studies and why such evidence may fail to accurately predict a drug's clinical utility. Some key issues include: insufficient consideration of all available evidence; use of weak study designs like non-randomized trials; industry sponsorship resulting in bias; lack of head-to-head comparisons; choice of populations and outcomes that do not reflect real-world use; publication and reporting biases that suppress negative results; and reliability issues with meta-analyses and clinical guidelines formed from potentially biased evidence. Solutions proposed include improving study registration and data sharing, requiring comparative evidence earlier, and conducting reviews in a more transparent and non-conflicted manner.

1. 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 MISHRA
PI/289

2. Contents
Future Aspects
Conclusions
Introduction
Clinical Trials
Problems &
Solution
2

3. Introduction
3

4. Phases Of Clinical Trials
4

5. 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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6. Insufficient Considerations of Evidence
Continuously
Updated
Assessments
Published Reports
May Not Cited
Focus On
Consulting Reviews
Disproportionate
research
6

7. Use Of Weak Study Designs
NON-RANDOMIZED
DESIGNS
RANDOMIZED DESIGNS
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8. 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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9. Lack Of Head-to-Head Comparisons
9

10. Choice Of Patient Populations
10

11. Choice Of Outcomes
Predict the
Real-World
Utility
It Includes
Composites
Of
Multiple
Outcomes
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12. Problems in the Reporting of Clinical Trials
PUBLICATION
BIAS REPORTING
PAUCITY OF
EVIDENCE ON HARMS
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13. Publication
Generally Reported
Positive Results
Unpublished Trials
Are Now Posted In
ClinicalTrials.gov.
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14. Bias Reporting
Selective Citation of
Clinical Studies
Selective Outcome
Reporting
14

15. Problems in the Evidence and in the Formation
of Recommendations from Studies of Drug
Effects
METAANALYSES
RELIABILITY OF CLINICAL PRACTICE
GUIDELINES
15

16. Solution of Clinical Trial’s Problems
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Potential Improvements
Study Registrations
Provision Of Raw Data

17. 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

18. Future Aspects
ENSURE
TRANSPARENCY
MEANINGFUL
AND ACCURATE
EVIDENCE
DEVELOP
TRANSFORMATIVE
IDEAS
ENHANCE PUBLIC
TRUST
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19. 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

20. Acknowledgments
O I wish to acknowledge to-
O Dr.SACHCHIDANAND SIR,
O Dr.M.CHOURASIA SIR,
O Dr.SHAILENDRA SIR,
O SOHNI MAM, and
O MY CLASSMATES.
O I THANK YOU ALL……
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