• Summary
• Background
• Meeting Materials

Summary:

On March 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar for stakeholders to share information and answer questions about the final guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.

During this webinar the FDA:

• Described how voluntary inclusion of some patient engagement activities may enhance the design and conduct of clinical studies;
• Described which patient engagement activities are generally not considered by the FDA to constitute an activity subject to the FDA's regulations regarding Institutional Review Boards (IRBs); and
• Clarified how sponsors can receive feedback from the FDA on plans to voluntarily include patient advisor input on their clinical study, through the Q-submission process

Background:

The FDA believes including input from patient advisors early in clinical study design may address common challenges, and could result in improved recruitment, retention, and adherence, faster study completion, fewer protocol deviations, as well as streamlined collection of data which is more focused on outcomes that matter to patients.

The FDA developed this guidance based on recommendations during the Patient Engagement Advisory Committee Meeting in October 2017 and feedback on a discussion document issued in November 2018 and draft guidance issued September 2019. This final guidance is intended to provide clarity to device developers, sponsors, and industry about how to use patient engagement in clinical studies to improve design and conduct.

Providing patients and their family caregivers the opportunity to provide their insights about a disease or medical 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 study 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 studies. 

Meeting Materials

Presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics", sub-section "Patient Engagement".