Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
This guidance focuses on patient engagement in the design and conduct of medical device clinical studies. It aims to help sponsors understand how to involve patient advisors to improve clinical studies, highlight benefits of early engagement, and clarify which activities are not subject to FDA regulations. The guidance does not cover study participant reimbursement, investigational device promotion, or dissemination of clinical study results.
Recommended Actions
- Identify and define roles for patient advisors early in the study planning process
- Provide education and training to patient advisors to enable effective contributions
- Incorporate patient advisor input before finalizing protocols and informed consent documents
- Document patient engagement activities for reference in marketing applications
- Consider engaging patient advisors for:
- Improving informed consent documents
- Optimizing follow-up schedules and data collection
- Identifying meaningful endpoints
- Developing patient-reported outcome measures
- Addressing recruitment and retention challenges
- Consult with FDA early regarding patient engagement approaches through the Q-Submission Program
- Work with IRBs to determine applicable requirements when needed
- Consider post-study engagement with patient advisors to improve future studies
Key Considerations
Clinical testing
- Patient advisors should not be study/research participants in the same study they are advising
- Input from patient advisors should be incorporated before final protocol submission to IRB
- Patient advisors can help identify meaningful endpoints and outcomes
- Patient advisors can provide input on follow-up visit schedules and data collection methods
Human Factors
- Patient advisors can help improve informed consent documents for better understanding
- Patient advisors can provide input on flexible options for follow-up visits to reduce participant burden
- Patient advisors can help identify barriers to recruitment and study participation
Other considerations
- Patient engagement activities with patient advisors are generally not considered research requiring IRB oversight
- Patient advisors should be identified and their roles defined early in study planning
- Patient advisors should be educated about clinical studies and disease management approaches
- Sponsors should consider involving patient advisors during early planning phases
- Patient advisors can help inform patient preference studies and patient-reported outcome measures
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- Patient-Reported Outcome Instruments in Medical Device Evaluation
Original guidance
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- HTML / PDF
- Issue date: 2022-01-26
- Last changed date: 2022-01-25
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP), Biologics
- ReguVirta summary file ID: 6d8540d3740d5598588358469a210262
This post is licensed under CC BY 4.0 by the author.