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Keywords:

  • medical product safety;
  • Bayesian safety trials;
  • rare events;
  • outcomes trials;
  • hierarchical modeling;
  • postmarketing safety surveillance

Safety assessment is essential throughout medical product development. There has been increased awareness of the importance of safety trials recently, in part due to recent US Food and Drug Administration guidance related to thorough assessment of cardiovascular risk in the treatment of type 2 diabetes. Bayesian methods provide great promise for improving the conduct of safety trials. In this paper, the safety subteam of the Drug Information Association Bayesian Scientific Working Group evaluates challenges associated with current methods for designing and analyzing safety trials and provides an overview of several suggested Bayesian opportunities that may increase efficiency of safety trials along with relevant case examples. Copyright © 2013 John Wiley & Sons, Ltd.