Rare Daily Staff

The Food and Drug Administration said it hosted the first meeting of the Patient Engagement Advisory Committee or PEAC, what FDA chairman Scott Gottlieb called “a significant step forward in the FDA’s efforts to broaden its engagement with patients.”

The advisory committee is the first to be comprised solely of patients, care-partners, and those who represent their needs. The FDA’s Center for Devices and Radiological Health established the committee as part of its effort to keep patients at the center of its work.

The meeting was focused on engaging patients in the clinical trial process from design to recruitment to enrollment and retention in clinical trials, and how the agency communicates about clinical trial results.

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.

“The FDA’s work requires us to establish objective, consistent criteria on which we base our decisions,” said Gottlieb. “But ultimately, the criteria we use to judge benefit and risk turn on the parameters that matter to patients. Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important.”

CDRH is working with a diverse group of outside partners 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 trial process and through the postmarket evaluation. This includes new guidance on patient preference information for premarket approvals, Humanitarian Device Exemption applications, de novo requests, and for inclusion in device labeling. This guidance describes 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 also worked to integrate real world evidence into the agency’s regulatory decision making process, with issuance of the real world evidence guidance two months ago. This guidance encourages stakeholders to leverage information contained in electronic health records, insurance claims databases, and registries to facilitate more efficient regulatory decisions for medical devices.

October 10, 2017

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