Supporting information may be found in the online version of this article.
Bayesian methods for design and analysis of safety trials†
Version of Record online: 30 JUL 2013
Copyright © 2013 John Wiley & Sons, Ltd.
Special Issue: Bayesian Methods in Drug Development and Regulatory Review
Volume 13, Issue 1, pages 13–24, January/Febuary 2014
How to Cite
Price, K. L., Amy Xia, H., Lakshminarayanan, M., Madigan, D., Manner, D., Scott, J., Stamey, J. D. and Thompson, L. (2014), Bayesian methods for design and analysis of safety trials. Pharmaceut. Statist., 13: 13–24. doi: 10.1002/pst.1586
- Issue online: 21 JAN 2014
- Version of Record online: 30 JUL 2013
- Manuscript Accepted: 28 JUN 2013
- Manuscript Revised: 22 MAY 2013
- Manuscript Received: 11 FEB 2013
- 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.