The FDA recommends using “patient advisors” to help improve medical device clinical trials, in a newly released draft guidance.
Because medical device trials include many endpoints as well as eligibility criteria that exclude some study participants living with the disease from participating in the trials, trials often take too long, cost too much for sponsors, increase burden for patients, and are delayed in providing beneficial medical technologies, the agency says.
“Patient advisors have experience living with a disease or condition and can be an advisor to improve the clinical investigation design and conduct, but they are not participating in the clinical investigation themselves,” said acting FDA Commissioner Ned Sharpless in a comment on the draft.
