Discussion Document on Patient Engagement in Device Trials

FDA has released a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/2017 Patient Engagement Advisory Committee meeting. The agency notes that device clinical trials designed with patient input may be more likely to enroll and retain patients, collect information meaningful to patients and other key stakeholders, and be successfully completed, according to the document.

The discussion document provides an overview on benefits and challenges to involving patients in the design, implementation and conduct, and clinical trial information dissemination. This discussion document also identifies ways sponsors might engage patients to design more patient-centric trials.

FDA is seeking comments from interested parties by 1/8/2019. The agency will use feedback received on the discussion document to help develop a draft guidance on the topic.