Title: Data monitoring in clinical trials : a case studies approach /
Authors: DeMets, David L., 1944-; Furberg, Curt; Friedman, Lawrence M., 1942-
Publisher: Springer,
Year: 2006
Subjects: Randomized Controlled Trials as Topic; Clinical Trials Data Monitoring Committees; Biomedical Research standards; Clinical trials Data processing.; Clinical trials Case studies.; Statistics
Abstract: This book will 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. It has an extensive 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 and analysis 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.
Contents: Introduction/Overview -- Monitoring Committees: Why and How -- Lessons Learned -- FDA and Clinical Trial Data Monitoring Committees -- General Benefit -- to Case Studies Showing Benefit from the Intervention -- Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience -- Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods -- Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint -- 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 -- Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results -- Challenges in Monitoring the Breast Cancer Prevention Trial --^ Data Monitoring Experience in the 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 -- The Data Monitoring Experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program -- General Harm -- to Case Studies Showing Harmful Effects of the Intervention -- Breaking New Ground: Data Monitoring in the Coronary Drug Project -- The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early -- Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation: Dealing With an Agonizing Trend --^ Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee -- Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post—Traumatic Shock -- Consideration of Early Stopping and Other Challenges in Monitoring the Heart and Estrogen/Progestin Replacement Study -- Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: Early Termination of the Doxazosin Treatment Arm -- Case 19: Data Monitoring Experience in the Moxonidine Congestive Heart Failure Trial -- Data Monitoring of a Placebo-Controlled Trial of Daclizumab in Acute Graft-Versus-Host Disease -- Special Issues -- to Case Studies With Special Issues -- Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee -- The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags --^ Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II -- Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity -- Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study -- Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree -- The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes -- Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer -- Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial.