Your data doing good: Our collaboration with the FDA

Posted December 21st, 2015 by

During #24DaysofGiving this December, we’ve been highlighting all the good your health data is doing. For this one, we wanted to share more about how the data you donate is the centerpiece of a new collaboration between PatientsLikeMe and the Food and Drug Administration (FDA).

Even after a new medication or treatment makes it through the rigorous clinical trial and FDA approval process, we still have a lot to learn about its impact in the real world. Clinical trials are considered the ‘gold standard’ of medical research, but they usually only account for a small fraction of the population that will eventually be prescribed that new treatment.

Today, the FDA reviews large claims data and uses a spontaneous reporting system of individual case safety reports to find out how a product is doing once it’s approved and in the market. If you think that sounds complicated and not very clear, you’re not alone. Basically, the FDA is waiting for a safety signal, dramatic event or adverse event (all fancy words for side effect) to happen that drug manufacturers are required to report. The problem is if you – the patient – or your doctor doesn’t submit a report about your experience to the drug manufacturer, then the drug manufacturer can’t report it to the FDA.

That’s why PatientsLikeMe and the FDA decided to collaborate this year. We wanted to see if patient-reported data from PatientsLikeMe could help the FDA identify new information about approved treatments when they are used outside of clinical trials. Since you generate the data, it provides important real-time insights into your experience over time, including drug tolerance, adherence and quality of life. In short, we’ll be learning if the aggregated real-world, longitudinal data you report can help the FDA better assess and manage risks.

But this isn’t entirely new to us here at PatientsLikeMe. We’ve actually been tracking the treatment effects you share about since 2008. In all, and thanks to your reporting, we’ve collected more than 110,000 side effect reports on 1,000 different medications. That’s information the FDA will now be able to study and analyze in addition to more traditional sources.

Now you know what’s behind our friendly emails and reminders when we ask you to update your treatments or complete a treatment evaluation during #24DaysofGiving. Everything you donate is going to help a whole lot of people!

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