Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint
Mixed methods, guided by a well-established implementation science framework, can be applied to ensure comprehensive formative and summative evaluations that provide fit-for-purpose information that may inform regulatory decision-making.
Authors
- Priya Bahri (ORCID: https://orcid.org/0000-0002-7798-6117)
- Meredith Y. Smith (ORCID: https://orcid.org/0000-0003-4542-5099)
- Viviana Nguyen
- Gita A. Toyserkani (ORCID: https://orcid.org/0000-0002-6946-6138)
- Alison Brown (ORCID: https://orcid.org/0000-0003-3998-7212)
- Rachel Davis (ORCID: https://orcid.org/0000-0003-2406-7181)
- Delphine Saragoussi
Institutions
- Ithaka Harbors (US)
- University of Southern California (US)
- European Medicines Agency (NL)
- United States Food and Drug Administration (US)
- University of North Carolina Wilmington (US)
- Sanofi (France) (FR)
- Neurobehavioral Systems (US)
- Center for the Study of Healthcare Provider Behavior (US)
Publication Details
- Journal
- Drug Safety
- Published
- 2025-03-12
- DOI
- https://doi.org/10.1007/s40264-025-01533-w
- Citations
- 2
- Primary Topic
- Health Policy Implementation Science
- Type
- article
- Field-Weighted Citation Impact
- 5.63