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The Food and Drug Administration (FDA) and PatientsLikeMe will work together to determine how patient-reported data can give new insights into drug safety.
FDA and PatientsLikeMe will partner to determine how patient-reported data can give new insights into drug safety.
Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.
PatientsLikeMe data is generated by patients, and provides important real-time insights into the nuances inherent in patients’ experiences over time, including drug tolerance, adherence and quality of life, according to a statement from PatientsLikeMe. Conversely, reporting adverse events to FDA is mandatory for drug product manufacturers but voluntary for healthcare professionals and patients. “The majority of these individual case safety reports are submitted by healthcare professionals and patients to drug product manufacturers, who then have regulatory requirements to report them to the FDA, according to the statement.
“Most clinical trials only represent the experience of several hundred or, at most, several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world,” said PatientsLikeMe Co-Founder and President Ben Heywood. “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. We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”
PatientsLikeMe is the largest and most active patient network online, with 350,000 members reporting on their real-world experiences with more than 2,500 conditions. The company has collected more than 110,000 adverse event reports on 1,000 different medications.
PatientsLikeMe’s drug safety initiatives began in 2008 with a pilot program that allowed patients with multiple sclerosis to report adverse events directly to FDA.