Data Monitoring in Clinical Trials: A Case Studies Approach - Brossura

Brossura

ISBN 10: 0387203303 ISBN 13: 9780387203300

Casa editrice: Springer, 2005

Riassunto

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.

Su questo libro

Recensione

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, or planning 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)

Contenuti

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

Dettagli dell?edizione

• Editore: Springer
• Data di pubblicazione: 2005
• ISBN 10: 0387203303
• ISBN 13: 9780387203300
• Rilegatura: Copertina flessibile
• Lingua: Inglese
• Numero di pagine: 400
• Redattore: DeMets David L., Furberg Curt D., Friedman Lawrence M.