File Size: 17747 KB
Print Length: 896 pages
Publisher: Academic Press; 2 edition (February 19, 2016)
Publication Date: February 19, 2016
Sold by: Digital Services LLC
Language: English
ASIN: B01CEBM1E0
Text-to-Speech: Enabled
X-Ray: Not Enabled
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Lending: Not Enabled
Enhanced Typesetting: Not Enabled
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I have recently evaluated this comprehensive guidebook, which describes all aspects of design, conduct, and interpretation of clinical research studies, and am highly impressed with both its scope and detail. Each chapter focuses on a different topic, all germane to the development of pharmaceuticals, and very useful to have collected together in one resource. The introductory material sets the stage, including helpful background on the structures of various types of drugs, the design and interpretation of animal models, and discussions of biosimilars and orphan drugs. The following two chapters detail the actual design of clinical trials, including extremely detailed advice for development of the overall study schema, the writing of the Clinical Trial Protocol, the determination of appropriate control groups, and the development of the important "run-in" period prior to treatment. Chapters 4 through 8 cover the critical trial design topics of inclusion/exclusion criteria, blinding, use of placebo groups, and the determination of "intent to treat" versus "per protocol" analysis. A further two chapters (8 and 9) also regard data analyses, with a fascinating -- and easy to understand -- discussion of biostatistics for the interpretation of trial results. Kaplan-Meier plots and One- or Two-tailed T-tests, for example, are not only explained in detail, but results from actual drug development trials are provided and placed in context. As the choice of endpoints for a clinical trial are critical for obtaining useful information regarding the actual activity of a possible therapeutic compound, Chapters 11 to 24 completely cover this topic, ranging from oncology, to immune and infectious diseases, and even "quality of life" studies.
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