Data Monitoring in Clinical Trials

DeMets, David L.; Furberg, Curt D.; Friedman, Lawrence M.

Data Monitoring in Clinical Trials

Edited by David L. DeMets, Curt D. Furberg and Lawrence M. Friedman

in Springer Books from Springer

Date: 2006
ISBN: 978-0-387-30107-5
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Chapters in this book:

Monitoring Committees: Why and How: David L. DeMets, Curt D. Furberg and Lawrence M. Friedman
Lessons Learned: David L. DeMets, Curt D. Furberg and Lawrence M. Friedman
FDA and Clinical Trial Data Monitoring Committees: Susan S. Ellenberg and Jay P. Siegel
Introduction to Case Studies Showing Benefit from the Intervention: David L. DeMets, Curt D. Furberg and 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 Experience in Formal Monitoring Methods: Lawrence M. Friedman, David L. DeMets and Robert Hardy
Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint: 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: John M. Lachin, Patricia Cleary, Oscar Crofford, Saul Genuth, David Nathan, Charles Clark, Frederick Ferris and Carolyn Siebert
Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results: Dianne M. Finkelstein
Challenges in Monitoring the Breast Cancer Prevention Trial: Carol K. Redmond, Joseph P. Costantino and Theodore Colton
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 G. Julian, John Wikstrand and Hans Wedel
Stopping the Randomized Aldactone Evaluation Study Early for Efficacy: Janet Wittes, Jean-Pierre Boissel, Curt D. Furberg, Desmond G. 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, D G Wyse and Salim Yusuf
The Data Monitoring Experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program: Stuart Pocock, Duolao Wang, Lars Wilhelmsen and Charles H. Hennekens
Introduction to Case Studies Showing Harmful Effects of the Intervention: David L. DeMets, Curt D. Furberg and Lawrence M. Friedman
Breaking New Ground: Data Monitoring in the Coronary Drug Project: Paul L. Canner
The Data Monitoring Experience 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: Dealing With an Agonizing Trend: Susan Anderson, Robert Cody, Milton Packer and Richard 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 J. Lewis and Norman Fost
Consideration of Early Stopping and Other 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 Treatment Arm: Barry R. Davis and Jeffrey A. Cutler
Case 19: Data Monitoring Experience in the Moxonidine 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 Zahrieh, Stephanie J. Lee and David Harrington
Introduction to Case Studies With Special Issues: David L. DeMets, Curt D. Furberg and Lawrence M. Friedman
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 and Byron W. Brown
Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II: Steven Snapinn and Curt D. Furberg
Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity: Charles H. Tegeler and Curt D. Furberg
Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study: James D. Neaton, Deborah N. Wentworth and Mark A. Jacobson
Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree: Janice Pogue and Salim Yusuf
The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes: Desmond G. Julian
Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer: Stephen L George and Mark R. Green
Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial: Janet Wittes, Eric Holmgren, Heidi Christ-Schmidt and Alex Bajamonde

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DOI: 10.1007/0-387-30107-0

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