FDA and PatientsLikeMe team up for research collaboration on patient-reported side effects

The US Food and Drug Administration has entered a research and collaboration agreement with online patient network PatientsLikeMe.

It aims to determine how patient-reported data can give new insights into drug safety, and will “explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.”

PatientsLikeMe has 350,000 members and has collected more than 110,000 adverse event reports relating to 1,000 drugs. It will remove any identifying information from the data that it provides to the FDA, and has not yet discussed with the agency what would be required if it wanted to follow up with a particular patient.