Risk evaluation and mitigation strategy assessments: Social science methodologies to assess goals related to knowledge

Abstract

On May 3, 2012, the US Food and Drug Administration announced a public workshop to receive input on “survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS [risk evaluation and mitigation strategy].” The FDA intended to use this input to help develop guidance to industry regarding best practices for such research. In the announcement to the meeting, entitled “Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: Public Workshop,” the FDA provided an issue paper summarizing experience with prior REMS assessment surveys and posing a series of questions for which input was requested from the workshop panel and public.

RTI Health Solutions (RTI-HS) participated in the workshop by serving on the invited panel (Alicia Gilsenan and Karol Krotki), presenting to the panel (Kelly Hollis, Sandy Lewis, and Laurie Zografos), and submitting written responses to the FDA to the questions posed in the issues paper accompanying the meeting announcement.

This paper provides a brief background and presents the written responses that RTI-HS submitted to the FDA, with modest revisions to add context and clarity to the response for a wider readership. We also briefly discuss upcoming US and European steps in this field.