Data and Safety Monitoring Committees in Clinical Trialsby 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… See more details below
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.
Table of Contents
What Is a Data Monitoring Committee (DMC)?
DMC in Federal Government–Sponsored Clinical Trials versus Pharmaceutical Industry Clinical Trials
Some Recent History
DMC’s Place in the Drug Development Cycle6
Pharmaceutical Industry Demographics
Organization of a Safety Monitoring Program for a Confirmatory Trial
Members of the Safety Monitoring Team
How Is a DMC Created?
Conflicts of Interest
Liability and Indemnification
Sponsor DMC Relationship
Interdisciplinary Training .
Types of Meetings
Ad Hoc Meetings
Goals of Safety Analysis .
Impact of Multinational Trials
Goals of Statistical Analysis
Useful Data Displays
Bias and Pitfalls
What Is Bias?
Sources of Bias.
Knowledge of Treatment Assignment
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
Special Problems with Infant Pharma Companies2
Issues in Technology.0
Issues Due to Maturing of DMC Processes and Evolution of the Pharmaceutical Industry
Resignation from a DMC.0
List of Abbreviations3
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