Data Monitoring in Clinical Trials

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 RandomizedMilrinone 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.