1. Introduction

  1. Guosheng Yin

Published Online: 9 JAN 2012

DOI: 10.1002/9781118183335.ch1

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

How to Cite

Yin, G. (2011) Introduction, in Clinical Trial Design: Bayesian and Frequentist Adaptive Methods, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118183335.ch1

Publication History

  1. Published Online: 9 JAN 2012
  2. Published Print: 19 DEC 2011

ISBN Information

Print ISBN: 9780470581711

Online ISBN: 9781118183335

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Keywords:

  • adaptive randomization;
  • Bayesian inference;
  • clinical trials;
  • hypothesis testing;
  • statistical methods

Summary

Clinical trials are prospective intervention studies with human subjects to investigate experimental drugs, new treatments, medical devices, or clinical procedures, under rigorously specified conditions. Conventionally, clinical trials are classified into four sequential phases: I, II, III, and IV. From phase I to phase IV trials and from fixed to adaptive designs, all study procedures need to ensure consistency and validity of the findings. Every aspect of the trial design, every stage of the trial conduct, and every interim monitoring and data analysis call upon statistical methods. Before stepping into statistical methods for clinical trial designs, this chapter first provides an overview of clinical trials. In the modern era of clinical trials, the study design and trial conduct become more sophisticated than ever, which, in turn, demands more advanced and adaptive statistical methods. To appreciate the importance and complexity of the process, the chapter presents three recent high-profile clinical trials.

Controlled Vocabulary Terms

Bayesian inference; hypothesis testing; statistical measures