Presentatio suji
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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
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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Unpublished Trials Are Now Posted In ClinicalTrials.gov.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
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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
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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
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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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