Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop in Brief


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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.