Assessing Drug Safety Using Bayesian Evidence Synthesis

• Activity Number: 208
• Type: Invited
• Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): David I. Ohlssen*+ and Amy Xia
• Companies: Novartis Pharmaceuticals Corporation and Amgen
• Keywords: Bayesian network meta-analysis ; rare events ; prior sensitivity ; reporting Bayesian analysis ; drug safety assessment

Abstract

The DIA Bayesian Scientific Working Group (BSWG) was formed in 2011 with a vision to ensure that Bayesian methods are well-understood and broadly utilized for design, and analysis and throughout the medical product development process, and to improve industrial, regulatory and economic decision making. The group comprised of individuals from academic, industry and regulatory, whose mission is to facilitate the appropriate use and contribute to the progress of Bayesian methodology. In this paper the safety sub-team of the BSWG explores the use of Bayesian methods when applied to drug safety meta-analysis and network meta-analysis. Guidance shall be presented on the design, conduct, analysis and reporting of such analyzes. Emphasis shall be placed on the selection of models and the choice of prior distributions, which can be of critical importance when dealing with rare safety events. The work will be illustrated by a case-study involving meta analyses relative to safety evaluation and a network meta-analysis related to the cardiovascular safety of non-steroidal anti-inflammatory drugs.