During last month’s DIA Annual meeting in Washington, D.C., online patient community PatientsLikeMe announced a research collaboration with the Food and Drug Administration to determine how patient-reported data can give new insights into drug safety.
PatientsLikeMe has 350,000 members with 2,500 conditions who report on their real-world experiences online. Patients, family members, or others interested may search for a particular patients, conditions, and treatments. For example, view the page for Rheumatoid Arthritis/Crohn’s treatment Remicade to see all of the patient-entered information; similar information is available for almost any drug.
The website’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. Using the example of Remicade again, users have reported around 70 side effects at this point- from fatigue, to headache, to nausea.
“Right now the FDA uses a voluntary reporting system consisting of individual case safety reports, the majority of which are submitted by healthcare professionals and patients to drug product manufacturers, who then are required to report them to the FDA,” states Sally Okun, Cive President, Advocacy, Policy & Patients Safety at PatientsLikeMe. “Our data are different in that the information is generated by patients themselves, and provide real-time insights about what its (sic) like to use medical products over time, like tolerability of the drug and factors that may influence taking the drug as prescribed.”
PatientsLikeMe Co-Founder and President Ben Heywood said the agreement is an unprecedented step toward enhancing post-market surveillance and informing regulatory science. “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. 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.”
While this is the first time that PatientsLikeMe has formally worked with the FDA, the collaboration adds to a foundation the company has built as an active participant in the regulatory science process. PatientsLikeMe has worked with, provided counsel to and co-authored discussion papers with a range of government groups, including the Institute of Medicine, the National Institute of Health, the Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services, as well as nonprofit organizations such as the Patient Centered Outcomes Research Institute (PCORI).
In the comment section to PatientsLikeMe shed some light onto how the FDA may use patient-entered side effects:
[T]he use of patient data may lead to FDA-sponsored research projects designed to understand how patient-reported data might be used to enhance post-market surveillance, support regulatory decision making and inform regulatory science.
It will be important to follow how this collaboration plays out, and how FDA makes use of a wide range of potentially complex patient experiences.