Scientific Publications by FDA Staff
Pharm Stat 2014 Jan-Feb;13(1):3-12
The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group.
Natanegara F, Neuenschwander B, Seaman JW Jr, Kinnersley N, Heilmann CR, Ohlssen D, Rochester G
Bayesian applications in medical product development have recently gained popularity. Despite many advances in Bayesian methodology and computations, increase in application across the various areas of medical product development has been modest. The DIA Bayesian Scientific Working Group (BSWG), which includes representatives from industry, regulatory agencies, and academia, has adopted the vision to ensure Bayesian methods are well understood, accepted more broadly, and appropriately utilized to improve decision making and enhance patient outcomes. As Bayesian applications in medical product development are wide ranging, several sub-teams were formed to focus on various topics such as patient safety, non-inferiority, prior specification, comparative effectiveness, joint modeling, program-wide decision making, analytical tools, and education. The focus of this paper is on the recent effort of the BSWG Education sub-team to administer a Bayesian survey to statisticians across 17 organizations involved in medical product development. We summarize results of this survey, from which we provide recommendations on how to accelerate progress in Bayesian applications throughout medical product development. The survey results support findings from the literature and provide additional insight on regulatory acceptance of Bayesian methods and information on the need for a Bayesian infrastructure within an organization. The survey findings support the claim that only modest progress in areas of education and implementation has been made recently, despite substantial progress in Bayesian statistical research and software availability.
|Category: Journal Article|
|PubMed ID: #24027093||DOI: 10.1002/pst.1595|
|Includes FDA Authors from Scientific Area(s): Tobacco|
|Entry Created: 2014-03-18|