Bayesian Methods in Regulatory Science

Research output: Contribution to journalArticle

Abstract

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)
JournalStatistics in Biopharmaceutical Research
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Bayes Theorem
Bayesian Methods
Clinical Trials
Decision Theory
Research
Regulator
Sample Size
Therapy
Efficacy
Drugs
Safety
Research Personnel
Equipment and Supplies
Therapeutics
Pharmaceutical Preparations
Experiment

Keywords

  • Clinical trials
  • Decision theory
  • Study design

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmaceutical Science

Cite this

Bayesian Methods in Regulatory Science. / Rosner, Gary L.

In: Statistics in Biopharmaceutical Research, 01.01.2019.

Research output: Contribution to journalArticle

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