Quantitative Benefit-Risk Assessment: State of the Practice Within Industry.

ABSTRACT:

Background

Benefit-risk assessments for medicinal products and devices have advanced significantly over the past decade. The purpose of this study was to characterize the extent to which the life sciences industry is utilizing quantitative benefit-risk assessment (qBRA) methods.

Methods

Semi-structured interviews were conducted with a sample of industry professionals working in drug and/or medical device benefit-risk assessments (n = 20). Questions focused on the use, timing, and impact of qBRA; implementation challenges; and future plans. Interviews were recorded, transcribed, and coded for thematic analysis.

Results

While most surveyed companies had applied qBRA, application was limited to a small number of assets-primarily to support internal decision-making and re

SUBMITTER: Smith MY 

PROVIDER: S-EPMC7864811 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature