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Handbook of adaptive designs in phar...

Chow, Shein-Chung, (1955-)

Handbook of adaptive designs in pharmaceutical and clinical development /

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Handbook of adaptive designs in pharmaceutical and clinical development /edited by Annpey Pong, Shein-Chung Chow.
other author:	Pong, Annpey.
Published:	Boca Raton, FL :CRC Press,c2011.
Description:	1 v. (various pagings) :ill. ;27 cm.
Subject:	Clinical trialsEvaluation.
ISBN:	9781439810163 (hbk.) :

Handbook of adaptive designs in pharmaceutical and clinical development /
Handbook of adaptive designs in pharmaceutical and clinical development /edited by Annpey Pong, Shein-Chung Chow. - Boca Raton, FL :CRC Press,c2011. - 1 v. (various pagings) :ill. ;27 cm.

Includes bibliographical references and index.

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

"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.

ISBN: 9781439810163 (hbk.) :NT$2838

LCCN: 2010037121

Nat. Bib. Agency Control No.: 101539161DNLMSubjects--Topical Terms:

393833
Clinical trials
--Evaluation.

LC Class. No.: R853.C55 / H355 2011

Dewey Class. No.: 615.5072/4

National Library of Medicine Call No.: QV 771

Handbook of adaptive designs in pharmaceutical and clinical development /
LDR:03741cam a2200277 a 4500 001 380847
003 DLC
005 20110628151807.0
008 130709s2011 flua bf 001 0 eng
010 $a 2010037121
016 7 $a 101539161 $2 DNLM
020 $a 9781439810163 (hbk.) : $c NT$2838
020 $a 1439810168 (hbk.)
035 $a (OCoLC)ocn660509874
035 $a 2010037121
040 $a DNLM/DLC $c DLC $d YDX $d NLM $d YDXCP $d CDX $d SOI $d DLC
042 $a pcc
050 0 0 $a R853.C55 $b H355 2011
060 1 0 $a QV 771
082 0 0 $a 615.5072/4 $2 22
245 0 0 $a Handbook of adaptive designs in pharmaceutical and clinical development / $c edited by Annpey Pong, Shein-Chung Chow.
260 $a Boca Raton, FL : $b CRC Press, $c c2011.
300 $a 1 v. (various pagings) : $b ill. ; $c 27 cm.
504 $a Includes bibliographical references and index.
505 0 $a 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
505 $a 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.
520 $a "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.
650 0 $a Clinical trials $v Evaluation. $3 393833
650 0 $a Drugs $x Research $x Methodology $v Handbooks, manuals, etc. $3 603574
650 1 2 $a Clinical Trials as Topic $x methods. $3 486907
650 2 2 $a Research Design. $3 219042
650 2 2 $a Statistics as Topic $x methods. $3 265580
700 1 $a Pong, Annpey. $3 603573
700 1 $a Chow, Shein-Chung, $d 1955- $3 188933