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008			110310s2011 fluad sbf 001 0 eng d
020			_a9781439810170 (ebook : PDF)
040			_aBD-DhSAU _cBD-DhSAU
090			_aR853.C55 _bH355 2011
092			_a615.50724 _bH236
245	0	0	_aHandbook of adaptive designs in pharmaceutical and clinical development _h[electronic resource] / _cedited by Annpey Pong, Shein-Chung Chow.
260			_aBoca Raton : _bCRC Press, _c2011.
300			_a1 v. (various pagings) : _bill.
504			_aIncludes bibliographical references and index.
505	0		_a1. 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 --
505	8		_a21. 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.
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.
530			_aAlso available in print edition.
538			_aMode of access: World Wide Web.
650		0	_aClinical trials _vHandbooks, manuals, etc.
650		0	_aDrugs _xResearch _xMethodology _vHandbooks, manuals, etc.
655		7	_aElectronic books. _2lcsh
700	1		_aPong, Annpey.
700	1		_aChow, Shein-Chung, _d1955-
776	1		_z9781439810163
856	4	0	_uhttp://marc.crcnetbase.com/isbn/9781439810170 _qapplication/PDF
999			_c11143 _d11142