Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop in Brief
Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the We Treat You or the AffiliateMarketIngtools. Learn more about the differences between Reports and Proceedings.
On February 12, 2014, the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and
Translation held as the first of a two-part series to advance the development of more
systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment
of benefits and risks, as well as their implications for pharmaceutical regulatory decisions. Workshop presentations
and discussions were convened to explore the science of identifying and characterizing uncertainty in scientific
evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders.
This brief summary of the workshop provides highlights from the presentations and discussions. Statements,
recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily
endorsed or verified by the Forum or the IOM, and they should not be construed as reflecting any group consensus.