FDA Wrestles With Social Media At Patient Engagement Meeting
US FDA device center's new Patient Engagement Advisory Committee held its second meeting on Nov. 15, focusing on the potential for social media and other patient-generated information to be a source of post-market medical device data.
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The topic is central to the Patient Engagement Advisory Committee, which recently got its tenure extended. It also fits into the FDA’s thinking on real-world evidence and total product lifecycle approach.
Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.
Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.