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Data monitoring in clinical trials [electronic resource] : a case studies approach / David L. DeMets, Curt D. Furberg, Lawrence M. Friedman, editors

Author
DeMets, David L., 1944-
Published
New York, NY : Springer, [2006]
Copyright Date
©2006
Physical Description
1 volume
Additional Creators
Furberg, Curt, Friedman, Lawrence M., 1942-, and SpringerLink (Online service)
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Contents
Section 1 -- Monitoring Committees: Why and How / David DeMets, Curt Furberg, Lawrence Friedman -- Lessons Learned / David DeMets, Curt Furberg, Lawrence Friedman -- FDA and Clinical Trial Data Monitoring Committees / Susan Ellenberg, Jay Siegel -- Section 2 -- Introduction to Case Studies Showing Benefit from the Intervention / David DeMets, Curt Furberg, Lawrence 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 Friedman, David DeMets, Robert Hardy -- Data Monitoring for the Aspirin Component of the Physicians' Health Study: Issues in Early Termination for a Major Secondary Endpoint / David DeMets, Charles 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 Hart, Lesly Pearce, Ruth McBride, Richard Kronmal -- Early Termination of the Diabetes Control and Complications Trial / John Lachin, Patricia Cleary, Oscar Crofford, Saul Genuth, David Nathan, Charles Clark, Frederick Ferris, Carolyn Siebert, DCCT Research Group -- Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results / Dianne Finkelstein -- Section 2 -- Challenges in Monitoring the Breast Cancer Prevention Trial / Carol Redmond, Joseph Costantino, 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 Julian, John Wikstrand, Hans Wedel -- Stopping the Randomized Aldactone Evaluation Study Early for Efficacy / Janet Wittes, Jean-Pierre Boissel, Curt Furberg, Desmond Julian, Henri Kulbertus, 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 Wyse, 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, Charles Hennekens -- Section 3 -- Introduction to Case Studies Showing Harmful Effects of the Intervention / David DeMets, Curt Furberg, Lawrence Friedman -- Breaking New Ground: Data Monitoring in the Coronary Drug Project / Paul Canner -- The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early / David DeMets, Lawrence Friedman -- Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation: Dealing With an Agonizing Trend / Susan Anderson, Robert Cody, Milton Packer, Richard Schwarz -- Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee / Anthony Miller, Julie Buring, O. Williams -- Section 3 -- Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post--Traumatic Shock / Roger Lewis, Norman Fost -- Consideration of Early Stopping and Other Challenges in Monitoring the Heart and Estrogen/Progestin Replacement Study / Stephen Hulley, Deborah Grady, Eric Vittinghoff, O. Williams -- Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: Early Termination of the Doxazosin Treatment Arm / Barry Davis, Jeffrey Cutler -- Case 19: Data Monitoring Experience in the Moxonidine Congestive Heart Failure Trial / Stuart Pocock, Lars Wilhelmsen, Kenneth Dickstein, Gary Francis, Janet Wittes -- Data Monitoring of a Placebo-Controlled Trial of Daclizumab in Acute Graft-Versus-Host Disease / David Zahrieh, Stephanie Lee, David Harrington -- Section 4 -- Introduction to Case Studies With Special Issues / David DeMets, Curt Furberg, Lawrence Friedman -- Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee / Richard Whitley -- The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags / David DeMets, George Williams, Byron Brown -- Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II / Steven Snapinn, Curt Furberg -- Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity / Charles Tegeler, Curt Furberg -- Section 4 -- Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study / James Neaton, Deborah Wentworth, Mark Jacobson -- Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree / Janice Pogue, Salim Yusuf -- The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes / Desmond Julian -- Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer / Stephen George, Mark Green -- Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial / Janet Wittes, Eric Holmgren, Heidi Christ-Schmidt, Alex Bajamonde
Subject(s)
ISBN
9780387301075
Note
Description based on print version record.
AVAILABLE ONLINE TO AUTHORIZED PSU USERS.
Bibliography Note
Includes bibliographical references and index.
Reproduction Note
Electronic reproduction. Berlin : Springer, 2006. Mode of access: World Wide Web. Available via SpringerLink.
View MARC record | catkey: 4563575