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FDA Statement

Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

For Immediate Release:
Statement From:
Norman E. "Ned" Sharpless, MD
Acting Commissioner of Food and Drugs - Food and Drug Administration

At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications. We value patient experience and insights about living with a disease, like diabetes or end-stage renal disease, as well as any impact a medical device—such as a glucose monitor or hemodialysis system—has had in a patient’s diagnosis, treatment and management of that disease. Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate.

How medical devices are tested to determine a favorable benefit/risk profile is at the core of our medical device evaluations, and the patient voice provides important value in that process. Typically, medical device developers work with health care providers, clinical researchers and the FDA to design and test medical devices to understand how the product will benefit patients, but the process often does not incorporate direct input from patients. Without patient input in the design and conduct of the clinical investigation, outcomes important to patients may not be captured, clinical visits may become overly burdensome and study enrollment could be negatively impacted. This can lead to increased time to conduct trials and increased burden to study participants and the health care system, resulting in delays in patient access to potentially lifesaving medical devices.

I believe that when we engage patients, their families and caregivers, throughout the medical device clinical investigation process, we will have more patient-centric clinical investigations and ultimately timely access to innovative, safe and effective medical devices. But, we recognize that encouraging patients to participate and complete clinical trials can be challenging.
That is why, today, we are releasing draft guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations. This draft guidance provides our proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design. The draft guidance is a reflection of our extensive work to engage patients into our medical product regulatory processes, which has grown since 1991 when the FDA first began including patient perspective in FDA Advisory Committee meetings, and continues today through our Patient Engagement Advisory Committee (PEAC). Launched in 2017, the PEAC is our first advisory committee whose members are solely patients, caregivers and those who represent their needs. Through PEAC, our Center for Devices and Radiological Health works with a diverse group of patient organizations to encourage the inclusion of patient perspectives across the total medical device life cycle, from the design and ideation of the medical device to the clinical investigation process, and through to post market monitoring. Patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues are among the topics that may be considered by the Committee.

It’s particularly exciting that today’s draft guidance is a direct result of the first PEAC meeting, which focused on ways to improve clincal trial design and improve recruitment, enrollment and retention in trials. As an outcome of that meeting, the PEAC recommended the FDA work with industry to develop a framework clarifying how patient advisors can engage in the clinical investigation process. Patient advisors have experience living with a disease or condition and can be an advisor to improve the clinical investigation design and conduct, but they are not participating in the clinical investigation themselves.

We provide proposed recommendations in the draft guidance on approaches sponsors might use to engage with patient advisors and outline some patient engagement activities that may enhance the design and conduct of clinical investigations. For example, patient advisors can help sponsors improve informed consent documents, so patients better understand the information being presented to them. Drawing from their personal experience, patient advisors can weigh in on outcomes that matter most to them to inform potential endpoints that are clinically meaningful in the treatment of a specific disease or condition.

We look forward to feedback from the patient community and sponsors on this draft guidance as it will help inform us as we continue to work with sponsors to ensure they integrate patient input into clinical investigations and other aspects of the regulatory process.

The FDA has also created engagement mechanisms to provide timely input from patients on what it is like to live with their disease or condition and/or interface with a medical device. One such effort is the Patient and Caregiver Connection program. Established in 2018, the pilot program was recently launched this summer and provides a formal process for FDA reviewers to engage with patients and patient organizations to obtain input on key issues when they are evaluating a medical device submission. This program allows us to broaden our exposure to patient experiences through patient organizations to address specific questions pertaining to their diagnosis and/or treatment. Along with today’s draft guidance, the Patient and Caregiver Connection program builds on our strong commitment to patients, who are our most important customers.

When we work with patients early-on, we can advance the development and evaluation of innovative medical devices. Patient-centric clinical investigations may improve efficiency and quality in the design and conduct of clinical investigations ensuring that sponsors can enroll and retain patients and collect information that is more meaningful to patients. This may lead to greater uptake of results by patients and providers when making treatment decisions and, ultimately, to earlier U.S. patient access to innovative, safe and effective medical devices.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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