Bayesian optimal response-adaptive design for binary responses using stopping rule

Stat Methods Med Res. 2018 Mar;27(3):891-904. doi: 10.1177/0962280216647210. Epub 2016 May 2.

Abstract

Response-adaptive designs are used in phase III clinical trials to allocate a larger number of patients to the better treatment arm. Optimal designs are explored in the recent years in the context of response-adaptive designs, in the frequentist view point only. In the present paper, we propose some response-adaptive designs for two treatments based on Bayesian prediction for phase III clinical trials. Some properties are studied and numerically compared with some existing competitors. A real data set is used to illustrate the applicability of the proposed methodology where we redesign the experiment using parameters derived from the data set.

Keywords: Bayesian design; ethics; non-informative prior; proportion of allocation; sample size; sequential design.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-HIV Agents / therapeutic use
  • Bayes Theorem*
  • Biostatistics / methods
  • Clinical Trial Protocols as Topic
  • Clinical Trials, Phase III as Topic / statistics & numerical data*
  • Computer Simulation
  • Early Termination of Clinical Trials / statistics & numerical data*
  • Female
  • HIV Infections / complications
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • Humans
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical / prevention & control
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy
  • Zidovudine / therapeutic use

Substances

  • Anti-HIV Agents
  • Zidovudine