Adaptive Design Methods in Clinical Trials, Second Edition

Shein-Chung Chow, Mark Chang

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December 1, 2011 by Chapman and Hall/CRC
Professional - 374 Pages - 33 B/W Illustrations
ISBN 9781439839874 - CAT# K11837
Series: Chapman & Hall/CRC Biostatistics Series

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Features

  • Discusses the FDA draft guidance on adaptive clinical trial designs
  • Includes power analysis for sample size calculations of adaptive group sequential designs
  • Covers genomic-guided/targeted clinical trials based on adaptive-biomarker design
  • Examines the impact of protocol amendments on clinical trial designs
  • Provides a comprehensive review of two-stage adaptive designs with different study objectives and endpoints at various stages
  • Outlines a Bayesian approach for the use of adaptive design methods in clinical trials
  • Presents examples of clinical trial simulation in early and late phases of development
  • Contains case studies on adaptive group sequential design, adaptive dose-escalation design, and two-stage phase II/III adaptive design

Summary

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.

New to the Second Edition
Along with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives.

Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.