Data and Safety Monitoring Committees in Clinical Trials

Data and Safety Monitoring Committees in Clinical Trials

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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 more

Product details

  • Hardback | 191 pages
  • 157.48 x 236.22 x 7.62mm | 385.55g
  • Taylor & Francis Ltd
  • Chapman & Hall/CRC
  • Boca Raton, FL, United States
  • English
  • 7 black & white illustrations, 39 black & white tables
  • 1420070371
  • 9781420070378
  • 1,797,188

Review quote

"I found this book very useful as a clinical biostatistician with little experience with serving on a DMC. But also biostatisticians with more experience in DMCs can profit from this book since it helps in evaluating their own performance. Though the book primarily focuses on pharmaceutical industry trials, it is almost equally useful for those working on investigator-initiated trials." -Theo Stijnen, ISCB News, December 2013 "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 6show more

About Jay Herson

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, USAshow more

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 Index7show more