• Report

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

Citation

Andrews, E., Davis, K., DiBenedetti, D., Forsyth, B., Gilsenan, A., Hollis, K., ... Zografos, L. (2014). Risk evaluation and mitigation strategy assessments: Social science methodologies to assess goals related to knowledge. (RTI Press Publication No. OP-0018-1401). Research Triangle Park, NC: RTI Press. DOI: 10.3768/rtipress.2014.op.0018.1401

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.

Author Details

Elizabeth Andrews

Elizabeth B. Andrews, PhD, MPH, FISPE, is vice president of Pharmacoepidemiology and Risk Management at RTI Health Solutions

Kimberly Davis

Kimberly H. Davis, MS, is a director in the Surveys and Observational Studies group of RTI Health Solutions.

Dana DiBenedetti

Dana B. DiBenedetti, PhD, is a head of RTI Health Solutions' Patient-Reported Outcomes group and is based in Dallas, Texas.

Barbara Forsyth

Barbara H. Forsyth, PhD, was a senior director of the Patient-Reported Outcomes group in RTI Health Solutions when this report was written.

Alicia Gilsenan

Alicia W. Gilsenan, PhD, is a senior director in RTI Health Solutions’ Epidemiology group.

Kelly Hollis

Kelly A. Hollis, MBA, is a global head in the Surveys and Observational Studies group of RTI Health Solutions.

Sandy Lewis

Sandy A. Lewis, BSN, RN, is a director in RTI Health Solutions’ Patient-Reported Outcomes group and is based in Jenkintown, Pennsylvania.

Mark Price

Mark A. Price, MA, MEd, is a director in the Survey and Observational Studies group in RTI Health Solutions.

Patricia Tennis

Patricia S. Tennis, PhD, MPH, FISPE, is a senior director in the Epidemiology group in RTI Health Solutions.

Laurie Zografos

Laurie J. Zografos, BS, is a senior director in the Surveys and Observational Studies group of RTI Health Solutions.