In September 2015, the FDA established the Patient Engagement Advisory Committee (PEAC) to provide guidance to the FDA Commissioner on “complex issues relating to medical devices, regulation of devices, and their use by patients.” The PEAC was formed to gather experts in clinical research, primary care patient experience, and health care needs of patient groups. Selected Committee members may also be “experienced in the work of patient and health professional organizations; methodologies for eliciting patient preferences; and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.”
It took over two years, but the Committee is finally having its inaugural meeting today and tomorrow. In a press release today, FDA Commissioner Scott Gottlieb, MD, called it “a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.” Dr. Gottlieb added that the PEAC is the FDA’s first advisory committee to be “comprised solely of patients, care-partners, and those who represent their needs. Founded by the FDA’s Center for Devices and Radiological Health (CDRH), it reflects CDRH’s commitment to keep patients at the center of their work.”
The CDRH has been actively gathering “patient perspectives across the total medical device life cycle, from the design and ideation of the medical device to the clinical trial process and through the postmarket evaluation.” The CDRH has provided new guidance on “how patient tolerance for risk and perspective on benefit can be considered as part of the FDA’s assessment of the benefit-risk of certain devices.” CDRH has worked to advance the development of patient preference studies and patient-reported outcome measures in a wide range of device areas ranging from prosthetic limbs to minimally invasive surgical devices designed to treat the eye condition of glaucoma.
Dr. Gottlieb said, “Today’s meeting of the PEAC is focused on engaging patients in the clinical trial process from design to recruitment to enrollment and retention in clinical trials, and how we communicate about clinical trial results.” Dr. Gottlieb concluded with this punchline: “When assessing whether valid scientific evidence shows that a device’s probable benefit outweighs its likely risks, the FDA can also consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing.”
The meeting is open to the public and is began today, Oct. 11th, at 1pm ET. It will continue until 5pm ET today and resume tomorrow, Oct. 12th, from 8am to 5pm ET. The location is the Grand Ballroom at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Maryland 20877.
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