FDA encourages patient engagement activities in clinical trials

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Patient Engagement in Design and Conduct of Medical Device Clinical Investigations.     This draft guidance, when finalized, is intended to: Provide clarity to device developers, sponsors and industry about patient engagement in clinical investigations.   Encourage device developers, sponsors and industry to engage with patient advisors early in the development process. Illustrate which patient engagement activities are generally not considered by the FDA to constitute research or an activity subject to the FDA’s regulations, including regulations regarding Institutional Review Boards (IRBs). Provide clarity about what to submit to the FDA regarding patient engagement in the design and conduct of a clinical investigation.

Read the Draft Guidance The FDA received feedback and recommendations during the Patient Engagement Advisory Committee Meeting in October 2017 and feedback on a discussion document issued in November 2018.  This draft guidance is intended to address that feedback and the recommendations by providing clarity to device developers, sponsors and industry about patient engagement in clinical investigations. Providing patients and their family caregivers the opportunity to provide their insights about a disease or condition, including living with that disease or condition as well as the impact of medical devices in the diagnosis, treatment, and management of their disease or condition, can inform and improve the clinical trial process. As a result, these patient engagement activities can help medical device developers obtain experience, perspectives, and other relevant information to improve the design and conduct of medical device clinical investigations.   This guidance does not address study/research participant reimbursement or compensation, promotion of investigational devices, or dissemination of clinical investigation results. Submit comments on this draft guidance  This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2019-D-3846.  Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.