Data Monitoring in Clinical Trials: A Case Studies Approach

Monitoring Committees: Why and How-David L. DeMets, Curt D. Furberg, Lawrence M. Friedman .-Lessons Learned-David L. DeMets .- FDA Perspective-Susan S. Ellenberg and Jay P. Siegel.- Introduction-Lawrence M. Friedman .- Assessing Possible Late Treatment Effects Early- The Diabetic Retinopathy Study Experience-Fred Ederer .- Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial- Early Experiences in Formal Monitoring Methods-Lawrence M. Friedman, David L. DeMets and Robert Hardy .- Data Monitoring for the Aspirin Component of the Physicians Health Study- Importance of Secondary Outcomes-David L. DeMets and Charles H. Hennekens .- 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-Robert G. Hart, Lesly A. Pearce, Ruth McBride and Richard A. Kronmal .- Early Termination of the Diabetes Control and Complications Trial - Methodologic Issues-John M Lachin, Patricia Cleary, Oscar Crofford, Saul Genuth, David Nathan, Charles Clark, Frederick Ferris, and Carolyn Sieberg for the DCCT Research Group .- Data Monitoring in the AIDS Clinical Trials Group Study #981- Conflicting Interim Results-Dianne Finkelstein .- Challenges in Monitoring the Breast Cancer Prevention Trial-Carol K. Redmond,Joseph P. Costantino andTheodore Colton .- Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure- Potentially High Risk Treatment in High Risk Patients-Jan Feyzi, Desmond Julian, John Wikstrand and Hans Wedel .- Stopping the Randomized Aldactone Evaluation Study Early for Efficacy-Janet Wittes, Jean-Pierre Boissel, Curt Furberg, Desmond Julian, Henri Kulbertus and Stuart Pocock .- Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events Trials- Avoiding Important Information Loss-Janice Pogue, David Sackett, George Wyse and SalimYusuf .- Data Monitoring in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program-Stuart Pocock, Duolao Wang,Lars Wilhelmsen andCharles Hennekens .- Intro-Curt D. Furberg .- Breaking New Ground - Data Monitoring in the Coronary Drug Project-Paul L. Canner .- Data Monitoring in the Cardiac Arrhythmia Suppression Trial - The Need to Be Prepared Early-David L. DeMets and Lawrence M. Friedman .- Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation Trial- Dealing with an Agonizing Trend-Susan Anderson, Robert Cody, Milton Packer andRichard Schwarz .- Stopping the Carotene and Retinol Efficacy Trial - The Viewpoint of the Safety and Endpoint Monitoring Committee-Anthony B. Miller, Julie Buring and O. Dale Williams .- Monitoring a Clinical Trial with Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post - Traumatic Shock-Roger L. Lewis and Norman Fost .- Challenges in Monitoring the Heart and Estrogen/progestin Replacement Study-Stephen B. Hulley,Deborah Grady, Eric Vittinghoff and O. Dale Williams .- Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial- Early Termination of the Doxazosin Arm-Barry R. Davis and Jeffrey A. Cutler .- Data Monitoring in the Moxonidone Congestive Heart Failure Trial-Stuart Pocock, Lars Wilhelmsen, Kenneth Dickstein, Gary Francis and Janet Wittes .- Data Monitoring of a Placebo-controlled Trial of Daclizumab in Acute Graft-versus-Host Disease-David Zahrich, Stephanie J. Lee and David Harrington .- Introduction-David L. DeMets .- Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee-Richard J. Whitley .- The Nocturnal Oxygen Therapy Trial Data Monitoring Experience - Problem with Reporting Lags-David L. DeMets, George W. Williams andByron W. Brown, Jr. .- The Cooperative North Scandinavian Enalapril Survival Study II Trial-Steven