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Adaptive design methods in clinical trials

Author: Shein-Chung Chow; Mark Chang
Publisher: Boca Raton, FL : CRC Press, ©2012.
Series: Chapman & Hall/CRC biostatistics series.
Edition/Format:   eBook : Document : English : 2nd edView all editions and formats
Summary:
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Chow, Shein-Chung, 1955-
Adaptive design methods in clinical trials.
Boca Raton, FL : CRC Press, ©2012
(DLC) 2011046596
(OCoLC)761361235
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Shein-Chung Chow; Mark Chang
ISBN: 9781439839881 1439839883
OCLC Number: 772458186
Notes: "A Chapman & Hall book."
Description: 1 online resource (xvi, 358 pages) : illustrations.
Contents: Protocol amendment --
Adaptive randomization --
Adaptive hypotheses --
Adaptive dose-escalation trials --
Adaptive group sequential design --
Statistical tests for adaptive seamless designs --
Adaptive sample size adjustment --
Two-stage adaptive design --
Adaptive treatment switching --
Bayesian approach --
Biomarker adaptive trials --
Target clinical trials --
Sample size and power estimation --
Clinical trial simulation --
Regulatory perspectives : a review of FDA draft guidance.
Series Title: Chapman & Hall/CRC biostatistics series.
Responsibility: Shein-Chung Chow, Mark Chang.

Abstract:

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second Edition Along with revisions throughout the text.

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"Those familiar with the first edition will find substantial updates as well as five entirely new chapters ... The scope is wide-ranging ..." -ISCB News, 59, June 2015 "In this second edition, the Read more...

 
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