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RSSData Monitoring in Clinical Trials | ||||||||||||||||||
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| Table of contents Section 1. Introduction/Overview 1. Monitoring Committees: Why and How David L. DeMets, Curt D. Furberg, Lawrence M. Friedman 2. Lessons Learned David L. DeMets, Curt D. Furberg, Lawrence M. Friedman 3. FDA and Clinical Trial Data Monitoring Committees Susan S. Ellenberg, Jay P. Siegel Section 2. General Benefit 4. Introduction to Case Studies Showing Benefit from the Intervention David L. DeMets, Curt D. Furberg, Lawrence M. Friedman 5. Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience Fred Ederer 6. Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods Lawrence M. Friedman, David L. DeMets, Robert Hardy 7. Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint David L. DeMets, Charles H. Hennekens 8. 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, Richard A. Kronmal 9. Early Termination of the Diabetes Control and Complications Trial John M. Lachin, Patricia Cleary, Oscar Crofford, Saul Genuth, David Nathan, Charles Clark, Frederick Ferris, Carolyn Siebert 10. Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results Dianne M. Finkelstein 11. Challenges in Monitoring the Breast Cancer Prevention Trial Carol K. Redmond, Joseph P. Costantino, Theodore Colton 12. Data Monitoring Experience in the Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure: Potentially High-Risk Treatment in High-Risk Patients Jan Feyzi, Desmond Julian, John Wikstrand, Hans Wedel 13. Stopping the Randomized Aldactone Evaluation Study Early for Efficacy Janet Wittes, Jean-Pierre Boissel, Curt D. Furberg, Desmond Julian, Henri Kulbertus, Stuart Pocock 14. 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, D G Wyse, Salim Yusuf 15. The Data Monitoring Experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program Stuart Pocock, Duolao Wang, Lars Wilhelmsen, Charles H. Hennekens Section 3. General Harm 16. Introduction to Case Studies Showing Harmful Effects of the Intervention David L. DeMets, Curt D. Furberg, Lawrence M. Friedman 17. Breaking New Ground: Data Monitoring in the Coronary Drug Project Paul L. Canner 18. The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early David L. DeMets, Lawrence M. Friedman 19. Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation: Dealing With an Agonizing Trend Susan Anderson, Robert Cody, Milton Packer, Richard Schwarz 20. Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee Anthony B. Miller, Julie Buring, O. Dale Williams 21. Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post—Traumatic Shock Roger J. Lewis, Norman Fost 22. Consideration of Early Stopping and Other Challenges in Monitoring the Heart and Estrogen/Progestin Replacement Study Stephen B. Hulley, Deborah Grady, Eric Vittinghoff, O. Dale Williams 23. Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: Early Termination of the Doxazosin Treatment Arm Barry R. Davis, Jeffrey A. Cutler 24. Case 19: Data Monitoring Experience in the Moxonidine Congestive Heart Failure Trial Stuart Pocock, Lars Wilhelmsen, Kenneth Dickstein, Gary Francis, Janet Wittes 25. Data Monitoring of a Placebo-Controlled Trial of Daclizumab in Acute Graft-Versus-Host Disease David Zahrieh, Stephanie J. Lee, David Harrington Section 4. Special Issues 26. Introduction to Case Studies With Special Issues David L. DeMets, Curt D. Furberg, Lawrence M. Friedman 27. Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee Richard J. Whitley 28. The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags David L. DeMets, George W. Williams, Byron W. Brown 29. Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II Steven Snapinn, Curt D. Furberg 30. Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity Charles H. Tegeler, Curt D. Furberg 31. Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study James D. Neaton, Deborah N. Wentworth, Mark A. Jacobson 32. Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree Janice Pogue, Salim Yusuf 33. The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes Desmond Julian 34. Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer Stephen L. George, Mark R. Green 35. Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial Janet Wittes, Eric Holmgren, Heidi Christ-Schmidt, Alex Bajamonde DRM-restrictions Printing: not available Clipboard copying: not available | ||||||||||||||||||
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