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Abstract:
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Patients are at the center of medical interventions. We believe that patients can and should bring their own experiences to bear in helping the regulatory agencies evaluate the benefit-risk profile of certain drugs, biologics, and devices. Recently, regulatory agencies, industry and academia expressed strong interest on how to use patient preference data to improve the current benefit risk assessment process in the medical product pipeline. QSPI recently formed a sub-committee on this topic and conducted a literature review on studies where patient preference information is used in clinical trials. In this presentation, I will discuss some quantitative methods for eliciting patient preferences and how such information can be used for benefit risk assessment for medical products. The results from the QSPI literature review and a few case studies will be presented.
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