Bayesian Methods in Regulatory Science

Research output: Contribution to journalArticlepeer-review


Regulatory science comprises the tools, standards, and approaches that regulators use to assess safety, efficacy, quality, and performance of drugs and medical devices. A major focus of regulatory science is the design and analysis of clinical trials. Clinical trials are an essential part of clinical research programs that aim to improve therapies and reduce the burden of disease. These clinical experiments help us learn about what works clinically and what does not work. The results of clinical trials support therapeutic and policy decisions. When designing clinical trials, investigators make many decisions regarding various aspects of how they will carry out the study, such as the primary objective of the study, primary and secondary endpoints, methods of analysis, sample size, etc. This article provides a brief review of the clinical development of new treatments and argues for the use of Bayesian methods and decision theory in clinical research.

Original languageEnglish (US)
Pages (from-to)130-136
Number of pages7
JournalStatistics in Biopharmaceutical Research
Issue number2
StatePublished - Apr 2 2020


  • Clinical trials
  • Decision theory
  • Study design

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmaceutical Science


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