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Features of Adaptive Design Methods in Clinical Trials - 2nd Ed (2012) PDF free download:
Many statistical and/or scientific issues in the area of adaptive clinical trial design have attracted considerable attention from clinical scientists and researchers from academia, the regulatory agencies, and the pharmaceutical industry since the first edition of this book was published in 2006. Most recently, the U.S. Food and Drug Administration (FDA) released a draft guidance for comments, which has generated more issues/concerns when utilizing adaptive design methods in clinical trials. These statistical and/or scientific issues include (i) the feasibility of the use of adaptive design methods in clinical trials, (ii) the validity and integrity of the commonly considered adaptive designs such as adaptive dose finding design and two-stage seamless adaptive designs, and (iii) the search for appropriate statistical methods under complicated adaptive designs (or less well-understood designs). As a result, there was a need for a second edition of this book to provide a comprehensive and unified summary of the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.
This revision maintains the same overall objectives and level of presentation as the first edition. Similar to the first edition, the new edition focuses on the concepts rather than technical details. It is written from a practical viewpoint at a basic mathematical and statistical level. Feedback from the first edition was gratifying. We received many positive comments from clinical scientists and researchers from academia, the regulatory agencies, including the FDA, and the pharmaceutical industry. Accordingly, we have kept our intuitive writing style as well as the emphasis on the concepts via numerous examples and
illustrations.
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