Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices

What You Need to Know? 👇

What is patient engagement in medical device clinical studies according to FDA guidance?

Patient engagement involves intentional, meaningful interactions with patient advisors who provide their experiences and perspectives to improve clinical study design and conduct, without participating as research subjects themselves.

When should sponsors involve patient advisors in medical device clinical studies?

Sponsors should engage patient advisors during early planning phases while the study plan is being developed, ideally before final protocols and informed consent documents are submitted to IRBs for review.

Do patient engagement activities require IRB approval under FDA regulations?

No, FDA generally does not consider patient engagement activities with patient advisors to constitute research subject to FDA regulations, so IRB requirements typically do not apply to these consultative interactions.

What are the key benefits of incorporating patient perspectives in medical device studies?

Benefits include faster recruitment and enrollment, greater participant retention, improved protocol adherence, increased diverse participation, fewer protocol revisions, better quality data, and more patient-relevant outcomes.

How can sponsors get FDA feedback on their patient engagement plans?

Sponsors can discuss patient engagement approaches through the Q-Submission Program and are encouraged to reference patient engagement activities in study plans and subsequent marketing applications to FDA.

What types of activities can patient advisors help with in clinical studies?

Patient advisors can improve informed consent documents, suggest flexible follow-up options, identify meaningful endpoints, inform patient-reported outcome measures, and help design patient preference studies for benefit-risk assessments.

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What You Need to Do 👇

Recommended Actions

1. Identify and define roles for patient advisors early in the study planning process
2. Provide education and training to patient advisors to enable effective contributions
3. Incorporate patient advisor input before finalizing protocols and informed consent documents
4. Document patient engagement activities for reference in marketing applications
5. 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
6. Consult with FDA early regarding patient engagement approaches through the Q-Submission Program
7. Work with IRBs to determine applicable requirements when needed
8. 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

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Relevant Guidances 🔗

• Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
• Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
• Patient-Reported Outcome Instruments in Medical Device Evaluation

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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 ID: 6d8540d3740d5598588358469a210262