Data Monitoring in Clinical Trials

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ISBN: 9780387301075

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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


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Avainsanat: MATHEMATICS / Probability & Statistics / General MAT029000

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