Handbook of adaptive designs in pharmaceutical and clinical development / edited by Annpey Pong, Shein-Chung Chow.

Other author Pong, Annpey.
Other author Chow, Shein-Chung, 1955-
Format Electronic
Publication InfoBoca Raton, FL : CRC Press,
Description1 v. (various pagings) : ill. ; 27 cm.
Supplemental ContentFull text available from Ebook Central - Academic Complete
Subjects
Clinical trials--Handbooks, manuals, etc.
Drugs--Research. --Methodology. --Handbooks, manuals, etc.
Clinical Trials as Topic--methods.
Research Design.
Statistics as Topic--methods.

Contents Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow -- Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y. H. Chi -- Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan -- The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong -- From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull -- Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein -- Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu -- Adaptive interim analyses in clinical trials / Gernot Wassmer -- Classical dose-finding trial / Naitee Ting -- Improving dose-finding: a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong -- Adaptive dose-ranging studies / Marc Vandemeulebroecke ... [et al.] -- Seamless phase I/II designs / Vladimir Dragalin -- Phase II/III seamless designs / Jeff Maca -- Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong -- Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger -- Hypothesis-adaptive design / Gerhard Hommel -- Treatment adaptive allocations in randomized clinical trials: an overview / Atanu Biswas and Rahul Bhattacharya -- Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon -- Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu -- Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls / Independent data monitoring committees / Steven Snapinn and Qi Jiang -- Targeted clinical trials / Jen-Pei Liu -- Functional genome-wide association studies of longitudinal traits / Jiangtao Luo ... [et al.] -- Adaptive trial simulation / Mark Chang -- Efficiency of adaptive designs / Nigel Stallard and Tim Friede -- Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee -- Good practices for adaptive clinical trials / Paul Gallo.
Abstract "This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail include regulatory perspectives and logistics issues in applying adaptive design methods"--Provided by publisher.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2010037121
ISBN9781439810163 (hardcover : alk. paper)
ISBN1439810168 (hardcover : alk. paper)

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