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News From the Food and Drug Administration
November 5, 2019

Enlisting Patients’ Input in Medical Device Trials

JAMA. 2019;322(17):1644. doi:10.1001/jama.2019.17815

The FDA is taking further steps to include a sometimes overlooked voice in the development of medical devices—the patient’s.

In a recently released draft guidance document, the agency suggested a number of ways that device manufacturers can use patients’ perspectives to navigate some of the challenges inherent in designing clinical trials of their products. “Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.

The draft guidance describes a role for patient advisors: people who’ve participated in a previous clinical trial for the same disease or device type, those who were screened for but didn’t participate in a similar trial, disease-specific patient organization representatives, healthy people who may participate in a diagnostic device study, or patients’ caregivers. To avoid conflicts of interest, patient advisors wouldn’t participate in studies for which they’re offering advice.

Some ways that the advisers might help manufacturers strengthen their clinical investigations include collaborating on more user-friendly informed consent documents, offering opinions on potential endpoints that are most clinically meaningful, and suggesting flexible options for patients to fulfill follow-up schedules—using mobile or online technologies or allowing clinical researchers to make phone or home visits, for example.

Sharpless noted that the FDA’s efforts to invite patients into the medical product regulatory processes began in 1991, when their perspectives were included in the agency’s advisory committee meetings. “Without patient input in the design and conduct of the clinical investigation, outcomes important to patients may not be captured, clinical visits may become overly burdensome, and study enrollment could be negatively impacted,” he said.