The US Food and Drug Administration is linking with PatientsLikeMe to gain access to patient-reported real world data that may offer new insights into drug safety.
The groups will “systematically explore” how patient-generated data could inform regulatory review activities related to risk assessment and management, in an unprecedented step to boost post-marketing drug surveillance.
“Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time,” noted PatientLikeMe co-founder and president Ben Heywood. “We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier”.
The patient network, which has 350 000 members, has collected more than 110,000 adverse-event reports on 1,000 drugs, and already has real-world research initiatives set up with drugmakers including AstraZeneca, Genentech and Actelion.