Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.
Biography
Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
"The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industrysponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the aspects of data safety monitoring committee (DMC) activities. A great feature of the book is the “DMCounselor” section at the end of each chapter, covering nearly 70 questions with answers, of which about 33% are for a DMC Chair, 30% for the DMC Biostatistician member, 30% for a DMC physician member, and the rest are for others (e.g., project manager)."
~ Daniel Jia, Journal of Biopharmaceutical Statistics"Nicely written and readable cover-to-cover, the author walks through every facet of a Data Monitoring Committee (DMC) beginning with an overview of their past and current place in drug development, to how they are organized and interfaced with other committees, and on to the specifics of how a typical meeting is split into an open and closed session. From there it moves on to clinical issues, including how SAEs are categorized, statistical methods, including Bayesian and frequentist conditional power calculations, common biases and pitfalls, and guidance for how DMC decisions are made. It concludes with emerging issues due to new clinical trial designs mandated by the FDA to speed up the drug development process."
~Donna Pauler Ankerst, Biometrics
