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Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics
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Data and Safety Monitoring Committees in Clinical Trials (Hardcover, 2nd edition)
Loot Price: R3,574
Discovery Miles 35 740
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Data and Safety Monitoring Committees in Clinical Trials (Hardcover, 2nd edition)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 19 working days
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Praise for the first edition: "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." -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.
General
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