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Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020

Key Points Question What were the key design characteristics of the pivotal trials supporting novel drugs approved by the US Food and Drug Administration (FDA) in 2020? Findings This cohort study of 49 drugs approved by the FDA in 2020 found that they were supported by 75 pivotal trials, of which nearly two-thirds were double-masked, more than three-fourths had a randomization component, nearly half used a surrogate measure as a primary end point, and more than one-fourth used a historical, external, or other control. Surrogate measures and historical controls were much more common among oncology drug approvals than among nononcology drug approvals. Meaning In this study, the cohort of 2020 novel drug approvals continued a trend of new drugs being supported by smaller numbers of preapproval pivotal trials and fewer features traditionally associated with rigor.