The what, why and how of Bayesian clinical trials monitoring

Stat Med. 1994 Jul;13(13-14):1371-83; discussion 1385-9. doi: 10.1002/sim.4780131312.

Abstract

We discuss the advantages and limitations of group sequential methods for monitoring clinical trials data. We describe a Bayesian approach, based upon the use of sceptical prior distributions, that avoids some of the limitations of group sequential methods. We illustrate its use with data from a trial of levamisole plus 5-Fluorouracil for colorectal cancer.

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bayes Theorem*
  • Bias
  • Clinical Trials as Topic / statistics & numerical data*
  • Colorectal Neoplasms / drug therapy
  • Colorectal Neoplasms / mortality
  • Colorectal Neoplasms / pathology
  • Data Interpretation, Statistical*
  • Fluorouracil / therapeutic use
  • Humans
  • Levamisole / therapeutic use
  • Neoplasm Staging
  • Proportional Hazards Models
  • Survival Analysis
  • Survival Rate

Substances

  • Levamisole
  • Fluorouracil