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.
Author(s): David L. DeMets (Editor), Curt D. Furberg (Editor), Lawrence M. Friedman (Editor)
Edition: 1
Year: 2005
Language: English
Pages: 400
Contents......Page 19
Preface......Page 5
Contributors......Page 8
Section 1: Introduction/Overview......Page 25
1 Monitoring Committees: Why and How......Page 26
2 Lessons Learned......Page 37
3 FDA and Clinical Trial Data Monitoring Committees......Page 62
Section 2: General Benefit......Page 73
Introduction to Case Studies Showing Benefit From the Intervention......Page 74
Case 1 Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience......Page 76
Case 2 Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods......Page 85
Case 3 Data Monitoring for the Aspirin Component of the Physicians' Health Study: Issues in Early Termination for a Major Secondary Endpoint......Page 94
Case 4 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......Page 106
Case 5 Early Termination of the Diabetes Control and Complications Trial......Page 114
Case 6 Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results......Page 130
Case 7 Challenges in Monitoring the Breast Cancer Prevention Trial......Page 139
Case 8 Data Monitoring Experience in the Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure: Potentially High-Risk Treatment in High-Risk Patients......Page 157
Case 9 Stopping the Randomized Aldactone Evaluation Study Early for Efficacy......Page 169
Case 10 Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events Trials: Avoiding Important Information Loss......Page 179
Case 11 The Data Monitoring Experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program......Page 187
Section 3: General Harm......Page 197
Introduction to Case Studies Showing Harmful Effects of the Intervention......Page 198
Case 12 Breaking New Ground: Data Monitoring in the Coronary Drug Project......Page 201
Case 13 The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need To Be Prepared Early......Page 216
Case 14 Data Monitoring in the Prospective Randomized Milrinone Survival Evaluation: Dealing with an Agonizing Trend......Page 227
Case 15 Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee......Page 238
Case 16 Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post-Traumatic Shock......Page 246
Case 17 Consideration of Early Stopping and Other Challenges in Monitoring the Heart and Estrogen/Progestin Replacement Study......Page 254
Case 18 Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: Early Termination of the Doxazosin Treatment Arm......Page 266
Case 19 Data Monitoring Experience in the Moxonidine Congestive Heart Failure Trial......Page 278
Case 20 Data Monitoring of a Placebo-Controlled Trial of Daclizumab in Acute Graft-Versus-Host Disease......Page 287
Section 4: Special Issues......Page 296
Introduction to Case Studies With Special Issues......Page 297
Case 21 Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee......Page 300
Case 22 The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags......Page 307
Case 23 Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II......Page 317
Case 24 Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity......Page 327
Case 25 Data Monitoring Experience in the AIDS Toxoplasmic Encephalits Study......Page 335
Case 26 Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree......Page 345
Case 27 The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes......Page 352
Case 28 Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer......Page 361
Case 29 Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial......Page 375
Appendix 1 Data Monitoring Committee Members......Page 383
Appendix 2 Case Study Acronym Key (Title)......Page 386
E......Page 387
N......Page 388
W......Page 389
