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
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
This is an excellent book to stand alongside (primarily) Ellenberg et al. and (to a lesser extent) DeMets et al. ! an excellent book not only for those who might sit on a DMC but also for the many people who have to set up DMCs, provide reports or data to them and, very importantly, receive their recommendations and have to act on them. --Simon Day, Pharmaceutical Statistics, 2011, 10 Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book--not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC. As a junior statistician, I found the end-of-chapter Q&A section to be invaluable, because it gives a behind-the-scenes peek at DMC meetings and interactions with sponsors. ! the author provides virtually all relevant topics pertaining to a DMC with clarity and insight. ! some readers with advanced statistical background will find this text nicely complements the book by Proschan, Lan, and Wittes (2009). ! In summary, audiences ranging from novice clinical research practitioners to biostatisticians will find this comprehensive guide to data and safety monitoring committees a valuable addition. --The American Statistician, November 2010, Vol. 64, No. 4 !Jay Herson provides a concise overview of DMCs in a useful and accessible format. For someone new to the area, this text will provide a valuable introduction quickly and effectively. At the same time, the presentation style will allow those with more knowledge to move through the material expeditiously, and they will also benefit. ! a valuable introduction to DMCs. ! an excellent overview of a complex subject. The material is presented in a very accessible format and is particularly well suited to new DMC members, or those considering such an opportunity. The material is very useful, the presentation is effective, and a strong recommendation is appropriate. --Biometrics, March 2010 !When searching for books about DSMCs, you will find that Ellenburg et al. (2002) published a book with an almost identical title to Herson's. ! overall I would recommend Herson's book as more readable and detailed. ! This book would be particularly useful for anyone who becomes a DSMC member for the first time or for sponsors so that they can have a greater understanding of the DSMC's role. ! --Andrea M. Rehman, London School of Hygiene and Tropical Medicine, Journal of the Royal Statistical Society, Series A, 2010 This book, lively and readable and reflecting real-world experiences and lessons from DMC safety monitoring, is a useful complement to other available texts on this subject. --Paul P. Gallo, Novartis Pharmaceuticals, Journal of Biopharmaceutical Statistics, 2009, Issue 6
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