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Design and analysis of clinical trials for predictive medicine. (English) Zbl 1309.92013

Chapman & Hall/CRC Biostatistics Series. Boca Raton, FL: CRC Press (ISBN 978-1-4665-5815-1/hbk; 978-1-4665-5816-8/ebook). xvii, 381 p. (2015).
Publisher’s description: This book provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics – from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.
This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.
The articles of this volume will not be indexed individually.

MSC:

92-02 Research exposition (monographs, survey articles) pertaining to biology
92B15 General biostatistics
92C50 Medical applications (general)
62P10 Applications of statistics to biology and medical sciences; meta analysis
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