title: Bayesian methods for design and analysis of safety trials.
abstract: 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.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Karen L
authors.initials: KL
authors.lastname: Price
authors.forename: H Amy
authors.initials: HA
authors.lastname: Xia
authors.forename: Mani
authors.initials: M
authors.lastname: Lakshminarayanan
authors.forename: David
authors.initials: D
authors.lastname: Madigan
authors.forename: David
authors.initials: D
authors.lastname: Manner
authors.forename: John
authors.initials: J
authors.lastname: Scott
authors.forename: James D
authors.initials: JD
authors.lastname: Stamey
authors.forename: Laura
authors.initials: L
authors.lastname: Thompson
mesh_terms: D001499:Bayes Theorem; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015201:Meta-Analysis as Topic; D012107:Research Design; D018570:Risk Assessment; D018401:Sample Size
keywords: Bayesian safety trials; hierarchical modeling; medical product safety; outcomes trials; postmarketing safety surveillance; rare events