Patients: Trust and transparency key to using social media, apps to gather data

Members of an FDA committee agreed that social media and digital technologies could help companies and the agency gather real-world data on adverse events and patient-reported outcomes, but the parties must be transparent in the intended use of the data and share outcomes with patients.

The Thursday meeting of the Patient Engagement Advisory Committee (PEAC) was intended to provide FDA with patient input on the best methods to collect postmarket data for devices beyond its existing tools of postmarket studies and patient registries. At the meeting, the agency said these existing tools have limitations including under reporting of adverse events, lengthy study timelines and challenges enrolling trials. The increased availability of mobile devices and sensor technology as well as social media could provide new platforms to enrich its existing tool kit to collect this information post market, the agency said at the meeting and in its briefing materials...