FDA Uses PatientsLikeMe Database to Improve Understanding of Postmarket Safety Data
The FDA is teaming up with PatientsLikeMe to determine how patient-reported data can give new insights into drug safety.
Under the research collaboration agreement, the FDA will be able to mine and analyze more than 110,000 adverse event reports on 1,000 different medications and use the results to inform regulatory review activities around risk assessment and risk management.
The effort will supplement the FDA Adverse Event Reporting System and other traditional drug safety information sources. PatientsLikeMe claims 350,000 members reporting on experiences with more than 2,500 medical conditions. At this point, the FDA relies on pharma companies, which are required to report drug report adverse events, and healthcare providers and patients, whose reporting is voluntary.
The online patient forum’s drug safety initiative began in 2008 with a pilot program that allowed multiple sclerosis patients to report adverse events directly to the FDA. A social media platform launched one year later.
Data are generated by patients themselves and provide real-time insights into the nuances of their experiences, including drug tolerance, adherence and quality of life, PatientsLikeMe notes.
FDA spokesman Kris Baumgartner says that exploring patient-generated data could lead to additional research projects designed to understand how the information might enhance postmarket surveillance, support decisionmaking and inform regulatory science.
The agreement was announced at the DIA annual meeting in Washington, D.C. — John Bechtel