Data Monitoring in Clinical Trials

From the contents:
Assessing Possible Late Treatment Effects Early- The Diabetic Retinopathy Study Experience.- Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial- Early Experiences in Formal Monitoring Methods.- Data Monitoring for the Aspirin Component of the Physicians Health Study- Importance of Secondary Outcomes.- Early Termination of the Stroke Prevention in Atrial Fibrillation I Trial- Protecting Participant Interests in the Face of Scientific Uncertainties and the Cruel Play of Chance.- Early Termination of the Diabetes Control and Complications Trial Methodologic Issues.- Data Monitoring in the AIDS Clinical Trials Group Study 981- Conflicting Interim Results.- Challenges in Monitoring the Breast Cancer Prevention Trial.- Costantino andTheodore Colton.- Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure.- Potentially High Risk Treatment in High Risk Patients.- Stopping the Randomized Aldactone Evaluation Study Early for Efficacy.- Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events Trials- Avoiding Important Information Loss.

From the reviews:"This book is a must-read for individuals serving on or supporting data monitoring committees as well as statisticians and other disciplines involved in the design and analysis of clinical trials with interim monitoring." Journal of Biopharmaceutical Sciences, Issue 6, 2006"This edited book gives a brief introduction to data-monitoring committees for clinical trials ... . It has been my experience that many persons asked to serve on data-monitoring committees have scientific or clinical expertise relevant to the trial, but have little or no understanding of the purpose of the data-monitoring committee ... . Such individuals would greatly benefit from reading this book prior to serving on a data-monitoring committee, as would anyone wishing to gain some insight into the responsibilities and challenges facing data-monitoring committees." (S. W. Lagakos, Short Book Reviews, Vol. 26 (1), 2006)"The chapters are clearly written, and the take-home lessons are apparent. The 70 contributing authors represent a full range of perspectives on data monitoring and give balanace to the exposition. ...In summary, the book achieves its goal and deserves a place in every medical school's library." (J. Wade Davis, Journal of the American Statistical Association, Vol. 102, No. 477, 2007)"This book is highly recommended for anyone who starts to serve on a DMC or is already a member of such a board, and also for people in academia, industry, and regulatory agencies as well as for students in biostatistics, epidemiology, clinical trails, and medical ethics." Iris Pigeot, Biometrics, December 2006)"This book illustrates the complexity of data monitoring processes through a series of case studies presented by many distinguished clinical trial experts. ... A total of 29 case studies have been discussed. ... This book would be quite useful for the researchers, investigators and individuals serving on the DMC, or planning to do so, who would like to understand the application