The FDA has released draft guidance on how medtech manufacturers should involve patients in the design and conduct of clinical trials.
The agency’s Patient Engagement Advisory Committee (PEAC) recommended the FDA work with industry to develop a framework that clarifies how patient advisors can engage in the clinical investigation process. Patient advisors are defined as those who have experience living with a disease or condition and can advise on how to improve the clinical investigation design and conduct but are not participating in the investigation.