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Statistics Applied to Clinical Trials

Cleophas, Ton J. MD, PhD
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Book Information
Edition: 4th
Publisher: Springer Nature
ISBN: 1-4020-9522-8 (1402095228)
ISBN-13: 978-1-4020-9522-1 (9781402095221)
New Edition: 94-007-2862-X
Binding: Hardcover
Copyright: 2009
Publish Date: 01/09
Weight: 2.15 Lbs.
Pages: 559
Subject Class: PHM (Pharmacy and Pharmaceutical Industry)
Remarks:
A New Edition of this Title is Available
Return Policy: Returns accepted up to 12 months provided no other recalls or return restrictions apply.
Table Of Contents: View
Contributing Authors: View
 
Class Specifications
Discipline: Pharmacology
Subject Definition: Clinical Trials as Topic-Meth; Data Interpret, Statistical
NLM Class: QV 771
LC Class: R301.27
Abstract: In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.

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