A Brief Report on Proposed Areas of International Harmonization of Real‐World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators
Our assessment of definitions provided among these four regulators lends us to propose distinct areas for harmonization based on our assessment of where regulators appear to align and highlight opportunities to address misalignment.
Authors
- Rachele Hendricks‐Sturrup (ORCID: https://orcid.org/0000-0002-3390-2583)
- Valerie J. Parker (ORCID: https://orcid.org/0000-0001-6505-8068)
- Mark McClellan
- Maryam Nafie
Institutions
- Duke University (US)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1002/pds.70127
- Citations
- 11
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 34.44