Posted by Michael Wonder on 14 Nov 2019
Researchers call on FDA to rethink guidance allowing use of surrogate outcomes
13 November 2019 - The US FDA needs to reconsider its use of surrogate outcomes in some guidance documents on developing treatments for infectious diseases, researchers from Harvard and George Washington University School of Medicine wrote in a review published Tuesday in JAMA Internal Medicine.
The review evaluated 22 FDA guidance documents, which included recommendations for pivotal clinical trials in 27 disease indications. For six indications (22%), only direct clinical outcomes were specified as primary endpoints, while for the other 21 indications, guidance documents recommended surrogate outcomes as sole primary endpoints or as part of composite primary endpoints.
“None of the recommendations for the use of surrogate measures matched the regulatory and scientific conditions favouring indirect outcomes in place of clinical outcomes,” they wrote.
