Title:
Handbook of adaptive designs in pharmaceutical and clinical development
Author:
Pong, Annpey.
ISBN:
9781439810170
Publication Information:
Boca Raton : CRC Press, 2011.
Physical Description:
1 v. (various pagings) : ill.
Contents:
1. Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow -- 2. Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y.H. Chi -- 3. Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan -- 4. The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong -- 5. From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull -- 6. Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein -- 7. Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu -- 8. Adaptive interim analyses in clinical trials / Gernot Wassmer -- 9. Classical dose-finding trial / Naitee Ting -- 10. Improving dose-finding : a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong -- 11. Adaptive dose-ranging studies / Marc Vandemeulebroecke ... [et al.] -- 12. Seamless phase I/II designs / Vladimir Dragalin -- 13. Phase II/III seamless designs / Jeff Maca -- 14. Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong -- 15. Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger -- 16. Hypothesis-adaptive design / Gerhard Hommel -- 17. Treatment adaptive allocations in randomized clinical trials : an overview / Atanu Biswas and Rahul Bhattacharya -- 18. Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon -- 19. Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu -- 20. Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls --
21. Independent data monitoring committees / Steven Snapinn and Qi Jiang -- 22. Targeted clinical trials / Jen-Pei Liu -- 23. Functional genome-wide association studies of longitudinal traits / Jiangtao Luo ... [et al.] -- 24. Adaptive trial simulation / Mark Chang -- 25. Efficiency of adaptive designs / Nigel Stallard and Tim Friede -- 26. Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee -- 27. 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.
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