JAMA Network
What The Study Did: This study of 105 new drugs examined how often the Food and Drug Administration extrapolates the findings of a drug's pivotal trial data to its approved indication in terms of disease severity, subtype or use with other medications. Extrapolation can lead to different clinical outcomes in practice than were observed in the pivotal trials.
Authors: Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital, Harvard Medical School in Boston, is the corresponding author.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jamanetworkopen.2022.7958)
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