FDA Releases Draft Guidance on Device Clinical Trials and Patient Engagement: Comment Now!


The US Food and Drug Administration (FDA) released a draft guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The purpose is to guide industry in accounting for patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives. The draft guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials. The idea is that patients must be willing and able to use a medical device in order for it to have a practical benefit, so understanding any potential barriers prior to conducting a clinical trial would be beneficial.


  • Patient engagement is defined as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.”

  • Patient advisors are “individuals who have experience living with a disease or condition, and can serve in an advisory or consultative capacity to improve clinical investigation design and conduct, but who are not study/research participants themselves.”

  • Patient advisors: 1) may provide valuable information for medical device clinical trial design, 2) may recommend improved subject experience, and 3) may improve the relevance of the clinical trial.

  • To avoid a conflict of interest, patient advisors should not be enrolled in the study for which they advised.

Questions and Answers about Patient Engagement:

  • Question 1: “What approaches might sponsors use to engage patient advisors to inform the design and conduct of medical device clinical investigations?”

    • Answer: Sponsors should be clear in their clinical investigation plan which activities are intended for research subjects and which are for patient advisors. Patient advisors who are educated about clinical trials and their disease or condition would be more beneficial and influential. Some activities that are suggested include:

      • Discussing what endpoints are meaningful to the patient

      • Ensuring the consent form is understandable

      • Understanding patient perspective on benefit-risk

      • Discussing potential burdens to data collection and follow-up

  • Question 2: “When can input be gathered from patient advisors and incorporated into the clinical investigation?”

    • Answer: Input from patient advisors should be taken into consideration before protocols and informed consent forms are submitted to the IRB for review, and they would potentially benefit from input as early as possible in their development.

  • Question 3: “What are the roles of IRBs and other institutional groups in patient engagement?”

    • Answer: Because communication with a patient advisor is not the same as the interaction with a research subject, the FDA’s research regulations for the IRB do not apply. If there is concern over any privacy issues, the FDA recommends consulting IRBs and Health Insurance Portability and Accountability Act (HIPAA) Privacy Boards for clarification.

  • Question 4: “How can a sponsor receive feedback on its patient engagement plan or patient­ centered study design from FDA?”

    • Answer: The sponsor may receive feedback from the FDA about their patient engagement approaches through the optional Q-Submission Program.

By engaging with patients and their caregivers to understand their perspectives on their disease or condition and medical devices used for the diagnosis, treatment, or management, sponsors may improve the design and conduct of their medical device clinical trials, which could increase enrollment and compliance, and result in high-quality data. This in return could result in the development of medical devices that are more meaningful to the target patients and that have greater impact on public health.

Comment now through November 22, 2019 here.


- The Clinical Pathways Team

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