Bayesian approaches in medical device clinical trials: A discussion with examples in the regulatory setting

Pablo Bonangelino, Telba Irony, Shengde Liang, Xuefeng Li, Vandana Mukhi, Shiling Ruan, Yunling Xu, Xiting Yang, Chenguang Wang

Research output: Contribution to journalArticlepeer-review

Abstract

Challenging statistical issues often arise in the design and analysis of clinical trials to assess safety and effectiveness of medical devices in the regulatory setting. The use of Bayesian methods in the design and analysis of medical device clinical trials has been increasing significantly in the past decade, not only due to the availability of prior information, but mainly due to the appealing nature of Bayesian clinical trial designs. The Center for Devices and Radiological Health at the Food and Drug Administration (FDA) has gained extensive experience with the use of Bayesian statistical methods and has identified some important issues that need further exploration. In this article, we discuss several topics relating to the use of Bayesian statistical methods in medical device trials, based on our experience and real applications. We illustrate the benefits and challenges of Bayesian approaches when incorporating prior information to evaluate the effectiveness and safety of a medical device. We further present an example of a Bayesian adaptive clinical trial and compare it to a traditional frequentist design. Finally, we discuss the use of Bayesian hierarchical models for multiregional trials and highlight the advantages of the Bayesian approach when specifying clinically relevant study hypotheses.

Original languageEnglish (US)
Pages (from-to)938-953
Number of pages16
JournalJournal of biopharmaceutical statistics
Volume21
Issue number5
DOIs
StatePublished - Sep 2011
Externally publishedYes

Keywords

  • Bayesian adaptive designs
  • Bayesian hierarchical models
  • Clinical significance
  • Multiregional clinical trial
  • Prior distribution
  • Regulatory agency
  • Subgroup analysis

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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