Data and Safety Monitoring Committees in Clinical Trials
Chapman & Hall/CRC (Verlag)
978-1-4200-7037-8 (ISBN)
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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.
John Hopkins University, Baltimore, Maryland, USA Pfizer Research & Development, Kent, UK National Taiwan University, Taipei, Taiwan National Taiwan University, Taipei Duke University School of Medicine, Durham, North Carolina, Georgia Southern University, Statesboro, USA
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
| Erscheint lt. Verlag | 17.3.2009 |
|---|---|
| Reihe/Serie | Chapman & Hall/CRC Biostatistics Series |
| Zusatzinfo | 50-150 equations - PPI 513 - 4/10 - Book is at PGK; 39 Tables, black and white; 7 Illustrations, black and white |
| Sprache | englisch |
| Maße | 156 x 235 mm |
| Gewicht | 408 g |
| Themenwelt | Medizin / Pharmazie |
| ISBN-10 | 1-4200-7037-1 / 1420070371 |
| ISBN-13 | 978-1-4200-7037-8 / 9781420070378 |
| Zustand | Neuware |
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