Handbook of adaptive designs in pharmaceutical and clinical development /

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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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Pong, Annpey, Chow, Shein-Chung, 1955-
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Boca Raton, FL : CRC Press, 2010.
Temas:
Clinical trials > Handbooks, manuals, etc.
Drugs > Research > Methodology > Handbooks, manuals, etc.
Clinical Trials as Topic > methods
Research Design
Statistics as Topic > methods
Études cliniques > Guides, manuels, etc.
Médicaments > Recherche > Méthodologie > Guides, manuels, etc.
Clinical trials
Drugs > Research > Methodology
handbooks.
Handbooks and manuals
Handbooks and manuals.
Guides et manuels.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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