US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience
Advances in the availability and analysis of real-world data (RWD) have enabled the generation of robust real-world evidence (RWE) to support regulatory decision making by the US Food and Drug Administration. Realizing the full potential of RWE in a regulatory environment requires cross-discipline expertise and collaboration to increase confidence in RWE-based approaches. The FDA's Advancing RWE Program was established to address this need by providing a new option for regulatory interactions on RWE-based approaches.
Authors
- John Concato (ORCID: https://orcid.org/0000-0003-2846-0503)
- Yueqin Zhao
- Theresa Kehoe (ORCID: https://orcid.org/0000-0002-1895-7252)
- Ann R. Punnoose (ORCID: https://orcid.org/0000-0001-5130-0271)
- Donna R. Rivera (ORCID: https://orcid.org/0000-0002-4565-4556)
- Mark Levenson (ORCID: https://orcid.org/0000-0001-8971-762X)
- Stefanie Kraus
- Yin Huang (ORCID: https://orcid.org/0000-0001-7333-2784)
- Jie Li (ORCID: https://orcid.org/0000-0002-1994-2271)
- Richard A. Forshee (ORCID: https://orcid.org/0000-0002-5805-2837)
- Kimberly Smith (ORCID: https://orcid.org/0009-0000-2346-5343)
- Kristen Miller
Institutions
- Center for Biologics Evaluation and Research (US)
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
- Yale University (US)
Publication Details
- Journal
- Clinical Pharmacology & Therapeutics
- Published
- 2025-04-27
- DOI
- https://doi.org/10.1002/cpt.3700
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 5.26