title: Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis.
abstract: 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.
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, 07936, USA.
authors.forename: David
authors.initials: D
authors.lastname: Ohlssen
authors.forename: Karen L
authors.initials: KL
authors.lastname: Price
authors.forename: H Amy
authors.initials: HA
authors.lastname: Xia
authors.forename: Hwanhee
authors.initials: H
authors.lastname: Hong
authors.forename: Jouni
authors.initials: J
authors.lastname: Kerman
authors.forename: Haoda
authors.initials: H
authors.lastname: Fu
authors.forename: George
authors.initials: G
authors.lastname: Quartey
authors.forename: Cory R
authors.initials: CR
authors.lastname: Heilmann
authors.forename: Haijun
authors.initials: H
authors.lastname: Ma
authors.forename: Bradley P
authors.initials: BP
authors.lastname: Carlin
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001499:Bayes Theorem; D002318:Cardiovascular Diseases / Q000139:chemically induced; D055808:Drug Discovery; D006801:Humans; D015201:Meta-Analysis as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal
keywords: drug safety meta-analysis; mixed treatment comparisons; multiple outcomes; network meta-analysis; prior sensitivity; rare events; reporting Bayesian analysis