A new framework to address challenges in quantitative benefit-risk assessment for medical products

In recent years, there has been a proliferation of regulatory and industry-wide initiatives on structured benefit-risk (BR) assessment. Examples of structured BR frameworks include the PrOACT-URL (Problem formulation, Objectives, Alternatives, Consequences, Trade-Offs, Uncertainties, Risk Attitude and Linked Decisions) from European Medicines Agency Work Package 3, multiple U.S. Food and Drug Administration guidance documents on benefit-risk assessment for medical devices, and U.S. Food and Drug Administration implementation plans for benefit-risk assessment in drug regulatory decision-making.

Source: Contemporary Clinical Trials - July 1, 2020 Category: Radiology Authors: Bo Fu, Xuefeng Li, John Scott, Weili He Source Type: research