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Adaptive Design Methods in Clinical Trials - 9781584887768

Un libro in lingua di Shein Chow Chung, Chang Mark edito da Taylor & Francis, 2006

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Adapting the trial and/or statistical procedure of on-going clinical trials based on accrued data--for example all the subjects dying--has been common practice for years, but regulators look a little askance at it. Chow (medicine, Duke U. and National Cheng-Kung U., Taiwan) and Chang, with a Massachusetts pharmaceutical company, suggest that if the trial were designed from the beginning to be adapted, the US Food and Drug Administration might be less skeptical. They explain how to incorporate into trial design possible adaptation in such areas as protocol, group sequence, sample size, and treatment switching. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)

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