The FDA has released draft guidance on how medtech manufacturers should involve patients in the design and conduct of clinical trials.
The agency’s Patient Engagement Advisory Committee (PEAC) recommended the FDA work with industry to develop a framework that clarifies how patient advisors can engage in the clinical investigation process. Patient advisors are defined as those who have experience living with a disease or condition and can advise on how to improve the clinical investigation design and conduct but are not participating in the investigation.
The draft guidance proposes ways that patient advisors can improve trial design and conduct, such as helping sponsors improve informed consent documents and weighing in on outcomes that matter most to them.
“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,” acting FDA commissioner Dr. Ned Sharpless said in a news release. “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.”
The FDA also recently created ways to gather timely patient input on living with their disease or condition and/or interacting with a medical device. It launched the pilot Patient and Caregiver Connection program in summer 2019 to provide 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.
“When we work with patients early on, we can advance the development and evaluation of innovative medical devices,” Sharpless said. “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 draft guidance may be found here.
