Researchers seek FDA transparency on use of surrogate endpoints outside of oncology

In a study pub­lished Mon­day in JA­MA, re­searchers are call­ing on the FDA to share more about how the agency con­sid­ers the use of sur­ro­gate mark­ers as pri­ma­ry end­points out­side of on­col­o­gy tri­als.

Sur­ro­gate end­points are used fre­quent­ly in can­cer tri­als for ac­cel­er­at­ed ap­provals. In oth­er dis­eases, the FDA has been more will­ing to ac­cept the un­cer­tain­ty from a sur­ro­gate mark­er, so long as a po­ten­tial drug could meet an un­met need and there are con­fir­ma­to­ry stud­ies on­go­ing.

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