Data monitoring in clinical trials : a case studies approach
著者
書誌事項
Data monitoring in clinical trials : a case studies approach
Springer, c2006
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998.
No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.
目次
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
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