Work

Opportunities and Risks of a Single-Trial Default for FDA Drug Approval

Year: 2026

Type: article

Abstract: This Viewpoint describes potential concerns and opportunities with a single-trial default for US Food and Drug Administration (FDA) drug approval.

Source: JAMA Health Forum

DOI: 10.1001/jamahealthforum.2026.2756

Authors: Reshma Ramachandran, Rachel E. Sachs, Patricia J. Zettler, Holly Fernandez Lynch

Institutions: Yale University, Washington University in St. Louis, The Ohio State University, University of Pennsylvania

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $5,000

OpenAlex ID: W7208735226

FWCI:

Cites: 3

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