Applied Clinical Trials
PatientsLikeMe and the FDA have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety.
PatientsLikeMe and the FDA have signed a research collaboration agreement 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. The announcement was made at the start of the Drug Information Association’s (DIA) annual meeting in Washington D.C.
The cornerstone of the FDA’s post-approval drug safety surveillance is adverse event reporting, which is mandatory for sponsors but voluntary for healthcare professionals and patients. Because PatientsLikeMe data are generated in a different context by patients themselves, it can provide important real-time insights into the nuances inherent in patients’ experiences over time, including drug tolerance, adherence and quality of life.
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’s drug safety initiatives began in 2008 with a pilot program that allowed patients living with Multiple Sclerosis (MS) to report adverse events directly to the FDA. One year later the company launched the first drug safety platform on social media, enabling industry partners to meet their regulatory obligations. In all, PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000 different medications, data that the FDA will now be able to access and analyze as a supplement to traditional sources, including FAERS.