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# Require More Breakthrough Postmarket Studies: Research
- URL: https://www.fdaweb.com/require-more-breakthrough-postmarket-studies-research/
- Published: 2024-08-28T12:00:00.000Z
- Updated: 2026-09-14T14:39:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157669

Researchers at Yale and Emory Universities say FDA should require postmarket studies for breakthrough therapy-designated indications approved based on surrogate markers, regardless of approval pathway. Writing at *JAMA Network Open*, the researchers [say](https://pubmed.ncbi.nlm.nih.gov/39190303/?ref=fdaweb.com) such postmarket tests would ensure that the drugs’ clinical benefits are confirmed.

The study looked at the 157 original indications with breakthrough therapy designation that FDA approved from 2013 to 2023\. They found that all accelerated approvals (52) and 58% of traditional approvals (61) were based on pivotal trials using surrogate markers as primary endpoints.

“Whereas all breakthrough therapy-designated accelerated approvals had FDA-required postmarketing studies, only 7% of traditional approvals based on surrogate marker primary endpoints had such studies,” the paper says. “These findings suggest that frequent use of surrogate markers as primary endpoints in pivotal studies without requiring postmarketing studies to verify clinical benefit could create uncertainties for patients and clinicians around the use of breakthrough therapy-designated drugs.”