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Attributes of Data and Safety Monitoring Committees in Clinical Trials 2nd Edition PDF
“Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book―not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC.”Data and Safety Monitoring Committees in Clinical Trials 2nd Edition PDF
-S. T. Ounpraseuth, The American Statistician
In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff.
The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition.
New to the Second Edition:
Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives.
Newly added interim analysis for efficacy and futility section.
DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc.
DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan)
Use of patient reported outcomes of safety
Use of meta analysis and data outside the trial
New ideas for training and compensation of DMC members
Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
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Illustrations of Data and Safety Monitoring Committees in Clinical Trials 2nd Edition PDF
For students of all the branches of medicine and surgery and health professionals that aspire to be greater and better at their procedures and medications. A renowned book by those who have read it and learnt from it. Many have already ordered it and is on the way to their home. Whether you work in the USA, Canada, UK or anywhere around the world. If you are working as a health professional then this is a must read.. The most reviewed on book Data and Safety Monitoring Committees in Clinical Trials 2nd Edition PDF is available for grabs now here on our website free. Whatever books, mainly textbooks we have in professional courses specially Medicine and surgery is a compendium in itself so understand one book you need to refer another 2-10 books. Beside this there are various other text material which needs to be mastered!! Only reference books are partially read but all other books have to be read, commanded and in fact read multiple times.
The Writers
Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.
Proportions of Data and Safety Monitoring Committees in Clinical Trials 2nd Edition PDF
- Publisher : Chapman and Hall/CRC; 2nd edition (March 22, 2019)
- Language : English
- Paperback : 241 pages
- International Standard Book Number-10 : 0367261278
- International Standard Book Number-13 : 978-0367261276
- Item Weight : 1.04 pounds
- Dimensions : 6.14 x 0.61 x 9.21 inches
- Best Sellers Rank: #3,218,690 in Books
Reviews From Customers
Dennis O. Dixon
The great contribution of this book is the vast collection of …
February 8, 2017
The great contribution of this book is the vast collection of real examples of DSMB service on trials sponsored by pharmaceutical companies (all appropriately anonymized of course). Coverage is encyclopedic, ranging from project initiation and development of the DSMB charter, to the role in monitoring quality of trial conduct, specification of details of experimental design, and interpretation of interim analyses. The bibliography is comprehensive and right up to date. As a reference it will be especially valuable for companies and DSMB members new to the enterprise.
SHF
Important second edition of an extremely important book
February 2, 2017
The first edition was very effective in preparing me for my first-time service on a data monitoring committee. Now the second edition provides a broader list of DMC responsibilities due to new regulations and new clinical trial methodology. It will generate a lot of creative thinking about what a DMC should be. I will use it to provide new directions to the DMCs that I serve on.
Ronald Blum
An invaluable and comprehensive resource for DSMC members and collaborators
April 12, 2017
A comprehensive rendering of all aspects of Data Monitoring Committee structure and function. A single source for all disciplines that serve on DSMBs or collaborate with DSMCs as the sponsor or the clinical research organization. This book belongs on our bookshelf for reading and as a reference.
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