Clinical Trial Data Monitoring Committees: The Basics and Some Controversies

Presented by Dr. Susan Ellenberg, Ph.D., Professor of Biostatistics, Perelman Medical School, University of Pennsylvania

Data monitoring committees (DMCs), also called Data and Safety Monitoring Boards (DSMBs) have been components of the clinical trials oversight process for over half a century. Over the years, a fair consensus has developed on many aspects of DMC/DSMB operations, such as DMC/DSMB meeting format, use of sequential designs to guide early termination decisions and the appropriate roles of study sponsors and trial investigators in DMC/DSMB meetings, but some issues remain controversial. Areas of discussion and/or change include: presentation of interim comparisons to the DMC/DSMB with actual treatment groups versus coded treatment groups; appropriate criteria for early termination; the types of data presented at DMC/DSMB meetings; the role of the DMC/DSMB in approving protocol changes and in implementing adaptations in trials using adaptive designs; and concerns about legal liability of DMC/DSMB members. In addition, the issue of which trials actually need the special oversight provided by an independent DMC/DSMB will be addressed.

Remarks by Dr. Cathie Spino and the lecture by Dr. Ellenberg will begin promptly at 3:00p.m.

Dr. Susan Ellenberg is Professor of Biostatistics, Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania. Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004 she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982-1988).

Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She is a recipient of the 2018 Janet Norwood Award and the 2019 F.N. David Award, both awards given to a female statistician for outstanding achievements. A second edition of her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was released in March 2019.

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