US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials

Marianne Razavi; Paul Glasziou; Farina Klocksieben; John P A Ioannidis; Iain Chalmers; Benjamin Djulbegović

doi:10.1001/jamanetworkopen.2019.11111

Abstract

1 min read

In this study, estimated magnitudes of effect were larger among studies for which the FDA did not require RCTs compared with studies for which it did. There was no clear threshold of treatment effect above which no RCTs were requested.

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