The Medical Device Innovation Consortium (MDIC) has published a new step-by-step framework approach to integrating patient preferences into medical device trials.

Developed by the MDIC along with the FDA, patient advocacy groups and the medical device industry, the framework outlines how regulatory and clinical teams can identify what matters most to patients, collect and measure patient input, communicate with the FDA on planning and include the patient perspective in clinical trial design, recruitment and outcomes.

Having direct patient input may reveal that patients are willing to take a substantial risk in exchange for the potential benefits, MDIC said. On the other hand, patient perspective “may suggest that a treatment must provide significant, not-yet-identified benefits before patients would be willing to accept the risk of a new approach” and participate.

Read the framework document here: https://bit.ly/3DFhaf1.