Handbook of adaptive designs in pharmaceutical and clinical development

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Last edited by LC Bot
July 29, 2011 | History

Handbook of adaptive designs in pharmaceutical and clinical development

"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.

Publish Date
Publisher
CRC Press
Language
English

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Previews available in: English

Book Details


Table of 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.

Edition Notes

Includes bibliographical references and index.

Published in
Boca Raton, FL

Classifications

Dewey Decimal Class
615.5072/4
Library of Congress
R853.C55 H355 2011

The Physical Object

Pagination
1 v. (various pagings) :

Edition Identifiers

Open Library
OL24893014M
Internet Archive
handbookadaptive00pong
ISBN 10
1439810168
ISBN 13
9781439810163
LCCN
2010037121
OCLC/WorldCat
660509874

Work Identifiers

Work ID
OL15988377W

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July 29, 2011 Created by LC Bot import new book