Guidance on the implementation and reporting of a drug safety Bayesian network meta‐analysis. (30th August 2013)

• Record Type: Journal Article
• Authors: Ohlssen, David; Price, Karen L.; Amy Xia, H.; Hong, Hwanhee; Kerman, Jouni; Fu, Haoda; Quartey, George; Heilmann, Cory R.; Ma, Haijun; Carlin, Bradley P.; Price, Karen; LaVange, Lisa
• Is Part Of: Pharmaceutical statistics. Volume 13:Number 1(2014:Jan./Feb.)
• Page Start: 55
• Page End: 70
• Publication Date: 2013-08-30
• Subjects: Pharmacy -- Statistical methods -- Periodicals; Pharmacy -- Statistics -- Periodicals; 615.10727
• DOI: 10.1002/pst.1592
• Languages: English
• ISSNs: 1539-1604

Abstract

<abstract abstract-type="main" id="pst1592-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <p id="pst1592-para-0001">The Drug Information Association 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, composed of individuals from academia, industry, and regulatory, has as its mission 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 is presented on the conduct and reporting of such analyses. We also discuss different structural model assumptions and provide discussion on prior specification. The work is illustrated through a case study involving a network meta‐analysis related to the cardiovascular safety of non‐steroidal anti‐inflammatory drugs. Copyright © 2013 John Wiley &amp; Sons, Ltd.</p> </abstract>