Data and Safety Monitoring Committees in Clinical Trials

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract ...

Data and Safety Monitoring Committees in Clinical Trials

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

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Data and Safety Monitoring Committees in Clinical Trials
Language: en
Pages: 191
Authors: Jay Herson
Categories: Medical
Type: BOOK - Published: 2009-03-13 - Publisher: CRC Press

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author’s experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC
Data and Safety Monitoring Committees in Clinical Trials, Second Edition
Language: en
Pages: 241
Authors: Jay Herson
Categories: Mathematics
Type: BOOK - Published: 2016-12-19 - Publisher: CRC Press

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
Quantitative Drug Safety and Benefit Risk Evaluation
Language: en
Pages: 408
Authors: William Wang, Melvin Munsaka, James Buchanan, Judy Li
Categories: Mathematics
Type: BOOK - Published: 2021-12-29 - Publisher: CRC Press

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to
Cancer and the Heart
Language: en
Pages: 634
Authors: Michael S. Ewer
Categories: Medical
Type: BOOK - Published: 2019-11-20 - Publisher: PMPH USA

In Cancer and the Heart, third edition, Dr. Ewer and colleagues at MD Anderson are joined by national and international authorities who contributed to the 28 chapters of this volume. The various authors present their insights into the effects of anticancer drugs and radiation treatment on the heart, and other
Statistical Approaches in Oncology Clinical Development
Language: en
Pages: 220
Authors: Satrajit Roychoudhury, Soumi Lahiri
Categories: Mathematics
Type: BOOK - Published: 2018-12-07 - Publisher: CRC Press

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant