In the world of drug development, clinical issues and statistical issues cannot be separated. All are scientific and all use applied logic. However, safety monitoring in pharmaceutical industry clinical trials through data monitoring committees (DMCs) is both an art and a science, requiring the use of sound judgment as well as sound scientific method. In Data and Safety Monitoring Committees in Clinical Trials, Jay Herson applies his years of experience serving on and providing statistical support to DMCs. He reviews the current state of DMCs and the best practices that have evolved using the same lively approach he employed when writing Herson’s Handout for the ALA newsletter Under the Curve, 1991–2004. Defining the stewardship role and inner workings of DMCs, Dr. Herson — Describes a DMC’s interactions with sponsors, data analysis centers, institutional review boards, and regulatory agencies Examines the biases and pitfalls in analyzing safety data, as well as other...

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