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|a UAMI
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|a Handbook of adaptive designs in pharmaceutical and clinical development /
|c edited by Annpey Pong, Shein-Chung Chow.
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|a Boca Raton, FL :
|b CRC Press,
|c 2010.
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|a 1 online resource (475 pages)
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|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.
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|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 [and others] -- 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 [and others] -- 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.
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|a Print version record.
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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|a Clinical trials
|v Handbooks, manuals, etc.
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650 |
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|a Drugs
|x Research
|x Methodology
|v Handbooks, manuals, etc.
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1 |
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|a Clinical Trials as Topic
|x methods
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|a Research Design
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|a Statistics as Topic
|x methods
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|a Études cliniques
|v Guides, manuels, etc.
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|a Médicaments
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|a Clinical trials
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|a Pong, Annpey.
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|a Chow, Shein-Chung,
|d 1955-
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|i has work:
|a Handbook of adaptive designs in pharmaceutical and clinical development (Text)
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|i Print version:
|a Pong, Annpey.
|t Handbook of Adaptive Designs in Pharmaceutical and Clinical Development.
|d Hoboken : CRC Press, ©2010
|z 9781439810163
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