Data Monitoring in Clinical Trials (eBook, PDF)

A Case Studies Approach
Redaktion: Demets, David L.; Friedman, Lawrence M.; Furberg, Curt D.

• Format: PDF

Produktbeschreibung

During the past three decades, clinical trials have evolved to become major research methodology for clinical medicine. Many statistical principles have been applied to the design, conduct, and anlysis of clinical trials, and these statistical methodologies continue to evolve as we apply clinical trials to an increasing array of research settings.

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Produktdetails

• Verlag: Springer US
• Seitenzahl: 374
• Erscheinungstermin: 22. Juni 2006
• Englisch
• ISBN-13: 9780387301075
• Artikelnr.: 37285191

Autorenporträt

David L. DeMets, University of Wisconsin, Madison, WI, USA / Curt D. Furberg, Wake Forest University School of Medicine, Winston-Salem, NC, USA / Lawrence Friedman, Bethesda, MD, USA

Inhaltsangabe

Introduction/Overview.- Monitoring Committees: Why and How.- Lessons Learned.- FDA and Clinical Trial Data Monitoring Committees.- General Benefit.- to Case Studies Showing Benefit from the Intervention.- Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience.- Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods.- Data Monitoring for the Aspirin Component of the Physicians' Health Study: Issues in Early Termination for a Major Secondary Endpoint.- 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.- Early Termination of the Diabetes Control and Complications Trial.- Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results.- Challenges in Monitoring the Breast Cancer Prevention Trial.- Data Monitoring Experience in the Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure: Potentially High-Risk Treatment in High-Risk Patients.- Stopping the Randomized Aldactone Evaluation Study Early for Efficacy.- Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events Trials: Avoiding Important Information Loss.- The Data Monitoring Experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Program.- General Harm.- to Case Studies Showing Harmful Effects of the Intervention.- Breaking New Ground: Data Monitoring in the Coronary Drug Project.- The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early.- Data Monitoring in the Prospective RandomizedMilrinone Survival Evaluation: Dealing With an Agonizing Trend.- Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee.- Monitoring a Clinical Trial With Waiver of Informed Consent: Diaspirin Cross-Linked Hemoglobin for Emergency Treatment of Post-Traumatic Shock.- Consideration of Early Stopping and Other Challenges in Monitoring the Heart and Estrogen/Progestin Replacement Study.- Data Monitoring in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: Early Termination of the Doxazosin Treatment Arm.- Case 19: Data Monitoring Experience in the Moxonidine Congestive Heart Failure Trial.- Data Monitoring of a Placebo-Controlled Trial of Daclizumab in Acute Graft-Versus-Host Disease.- Special Issues.- to Case Studies With Special Issues.- Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee.- The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags.- Stopping a Trial for Futility: The Cooperative New Scandinavian Enalapril Survival Study II.- Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity.- Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study.- Data Monitoring in the Randomized Evaluation of Strategies for Left Ventricular Dysfunction Pilot Study: When Reasonable People Disagree.- The Data Monitoring Experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: Hazards of Changing Primary Outcomes.- Controversies in the Early Reporting of a Clinical Trial in Early Breast Cancer.- Making Independence Work: Monitoring the Bevacizumab Colorectal Cancer Clinical Trial.

Rezensionen

From the reviews:

"This book is a must-read for individuals serving on or supporting data monitoring committees as well as statisticians and other disciplines involved in the design and analysis of clinical trials with interim monitoring." Journal of Biopharmaceutical Sciences, Issue 6, 2006

"This edited book gives a brief introduction to data-monitoring committees for clinical trials ... . It has been my experience that many persons asked to serve on data-monitoring committees have scientific or clinical expertise relevant to the trial, but have little or no understanding of the purpose of the data-monitoring committee ... . Such individuals would greatly benefit from reading this book prior to serving on a data-monitoring committee, as would anyone wishing to gain some insight into the responsibilities and challenges facing data-monitoring committees." (S. W. Lagakos, Short Book Reviews, Vol. 26 (1), 2006)

"The chapters are clearly written, and the take-home lessons are apparent. The 70 contributing authors represent a full range of perspectives on data monitoring and give balanace to the exposition. ...In summary, the book achieves its goal and deserves a place in every medical school's library." (J. Wade Davis, Journal of the American Statistical Association, Vol. 102, No. 477, 2007)

"This book is highly recommended for anyone who starts to serve on a DMC or is already a member of such a board, and also for people in academia, industry, and regulatory agencies as well as for students in biostatistics, epidemiology, clinical trails, and medical ethics." Iris Pigeot, Biometrics, December 2006)

"This book illustrates the complexity of data monitoring processes through a series of case studies presented by many distinguished clinical trial experts. ... A total of 29 case studies have been discussed. ... This book would be quite useful for the researchers, investigators and individuals serving on the DMC, orplanning to do so, who would like to understand the application of data monitoring principles in clinical trials. I have thoroughly enjoyed reading this book and I think it has served its purpose ... ." (Faisel Yunus, Journal of Applied Statistics, Vol. 35 (5), 2007)