Data and Safety Monitoring Committees in Clinical Trials

Data and Safety Monitoring Committees in Clinical Trials

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by Jay Herson
     
 

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations

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Overview

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

Product Details

ISBN-13:
9781420070378
Publisher:
Taylor & Francis
Publication date:
03/18/2009
Series:
Chapman & Hall/CRC Biostatistics Series, #30
Pages:
192
Product dimensions:
6.30(w) x 9.30(h) x 0.60(d)

Table of Contents

Introduction
What Is a Data Monitoring Committee (DMC)?
Some Definitions
DMC in Federal Government–Sponsored Clinical Trials versus Pharmaceutical Industry Clinical Trials
Stewardship
Some Recent History
DMC’s Place in the Drug Development Cycle6
Pharmaceutical Industry Demographics
Conclusion
DMCounselor

Organization of a Safety Monitoring Program for a Confirmatory Trial
Members of the Safety Monitoring Team
How Is a DMC Created?
Membership
Term
Conflicts of Interest
Compensation
Liability and Indemnification
Sponsor DMC Relationship
Interdisciplinary Training .
Conclusion
DMCounselor

Meetings

DMC Charter
Types of Meetings
Orientation Meeting
Data ReviewMeetings
Ad Hoc Meetings
Conclusion
DMCounselor

Clinical Issues

Goals of Safety Analysis .
Definitions
Safety Data
Deaths .
Impact of Multinational Trials
Conclusion
DMCounselor

Statistical Issues

Goals of Statistical Analysis
Useful Data Displays
Analysis Methods—Frequentist
Power
Multiplicity
Analysis Methods—Likelihood
Analysis Methods—Bayesian.
Conclusion
DMCounselor

Bias and Pitfalls

What Is Bias?
Sources of Bias.
Knowledge of Treatment Assignment
Reporting Bias
Competing Risks
Conclusion
DMCounselor

Data Monitoring Committee Decisions
.1
Types of DMC Decisions 1
Decision-Making Environment .2
Risk versus Benefit Analyses2
When a Safety Issue Arises.3
Information beyond the Present Trial.8
Meta-Analysis0
Final Meeting2
Special Problems with Infant Pharma Companies2
Conclusion3
DMCounselor .3

Emerging Issues9
Introduction.9
Issues in Technology.0
Issues Due to Maturing of DMC Processes and Evolution of the Pharmaceutical Industry
Resignation from a DMC.0
Conclusion0
DMCounselor .1

Appendix5
Glossary1
List of Abbreviations3
References
5
Index7

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