Randomized clinical trials are the gold standard for establishing
many clinical practice guidelines and are central to evidence based
medicine. Obtaining the best evidence through clinical trials must
be done within the boundaries of rigorous science and ethical
principles. One fundamental principle is that trials should not
continue longer than necessary to reach their objectives.
Therefore, trials must be monitored for recruitment progress,
quality of data, adherence to patient care or prevention standards,
and early evidence of benefit or harm. Frequently, a group of
external experts, independent from the investigators and trial
sponsor, is charged with this monitoring responsibility, especially
for safety and early benefit. This group is referred to by various
names, such as a data monitoring committee or a data and safety
monitoring board. This book, through a series of case studies
presented by many distinguished clinical trial experts, illustrates
the complexity of this monitoring process. The editors provide an
overview of the process and a summary of a multitude of the lessons
learned from the cases presented.
This book should be useful to anyone serving on a data and
safety monitoring board, or planning to do so, for colleagues in
academia, industry and governmental agencies, and for teaching
students in biostatistics, epidemiology, clinical trials and
medical ethics. No other text has as extensive a collection of
cases which provide insight into the many issues, often
conflicting, that must be examined before recommendations to
continue or discontinue a trial can be made. While depth in
statistical methods is not required, some familiarity with
statistical design andanalysis issues in clinical trials is
helpful. The cases cover trials which were terminated early for
convincing evidence of benefit, or for harmful effects. Cases with
complex issues are also included. This series of cases should
provide broad background information for potential monitoring
committee members and better prepare them for the challenges that
may exist in the trials for which they are responsible.
The three editors have contributed two overview chapters as well
as several case studies to go along with cases contributed by a
distinguished group of colleagues experienced in the design,
monitoring and analysis of clinical trials. Dr. David DeMets is
currently Professor and Chair, Department of Biostatistics and
Medical Informatics at the University of Wisconsin-Madison. He is
past president of the Eastern North American Region (ENAR) of the
International Biometric Society, a past member of the Board of
Directors of the American Statistical Association and an elected
Fellow. He recently received the Robert Gordon Lectureship Award,
given by the National Institutes of Health, for significant
contributions to the field of clinical trials. Dr. Curt Furberg, is
currently Professor (and former Chair) of the Department of Public
Health Sciences at Wake Forest University. Previously, he was Head
of the Clinical Trials Branch and Associate Director of the
Clinical Applications and Prevention Program at the National Heart,
Lung, and Blood Institute. Dr. Lawrence Friedman is a former
Director of the Division of Epidemiology and Clinical Applications
and a former Assistant Director for Ethics and Clinical Research at
the National Heart, Lung, and Blood Institute. All three arepast
presidents of the Society of Clinical Trials. The editors have
collaborated previously as coauthors of a text: the Fundamentals of
Clinical Trials.
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