Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021

Anjali D Deshmukh; Aaron S Kesselheim; Benjamin N Rome

doi:10.1001/jamahealthforum.2023.0217

Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021

JAMA Health Forum. 2023 Mar 3;4(3):e230217. doi: 10.1001/jamahealthforum.2023.0217.

Authors

Anjali D Deshmukh^{1

2}, Aaron S Kesselheim^{1

3}, Benjamin N Rome^{1

3}

Affiliations

¹ Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
² Georgia State University College of Law, Atlanta, Georgia.
³ Harvard Medical School, Boston, Massachusetts.

No abstract available

Plain language summary

This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antineoplastic Agents*
Drug Approval

Substances

Antineoplastic Agents