Opportunities and Risks of a Single-Trial Default for FDA Drug Approval
This Viewpoint describes potential concerns and opportunities with a single-trial default for US Food and Drug Administration (FDA) drug approval.
Authors
- Patricia J. Zettler (ORCID: https://orcid.org/0000-0001-9114-0735)
- Holly Fernandez Lynch (ORCID: https://orcid.org/0000-0001-7813-9879)
- Rachel E. Sachs (ORCID: https://orcid.org/0000-0002-0172-3572)
- Reshma Ramachandran
Institutions
- William Carey University (US)
- Washington University in St. Louis (US)
- Yale University (US)
- University of Pennsylvania (US)
Publication Details
- Journal
- JAMA Health Forum
- Published
- 2026-09-04
- DOI
- https://doi.org/10.1001/jamahealthforum.2026.2756
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00