The FDA is set to investigate whether patient-reported data can give it new insights into the safety of the products it approves.
The US regulator has teamed up with online patient community PatientsLikeMe to explore how the data that patients generate could “inform regulatory review activities related to risk assessment and risk management”.
PatientsLikeMe co-founder and president Ben Heywood said the agreement was an “unprecedented step toward enhancing post-market surveillance and informing regulatory science”.
He added: “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.”
At present the majority of post-approval drug safety reports reach the FDA from drug manufacturers, and are either recorded directly by the company or submitted by healthcare professionals (HCPs) and patients.
Firms have to report any reports they receive, but HCPs and patients – who can also send reports directly to the regulatory via the FDA Adverse Event Reporting System (FAERS) – are not obliged to contact the FDA about their drug safety concerns.
PatientsLikeMe said its data is of different kind to that the FDA receives from FAERS, being generated in a different context by patients themselves. The company hopes it will provide real-time insights into the nuances inherent in patients’ experiences of particular medicines, including information on drug tolerance, adherence and quality of life.
Formed in 2004 with an initial focus on the neurodegenerative disease ALS (amyotrophic lateral sclerosis), PatientsLikeMe now covers over 2,500 different conditions and has more than 350,000 members.
Its latest research collaboration is the first time PatientsLikeMe has formally worked with the FDA, but its drug safety work has been going since 2008, when it launched a pilot programme that allowed multiple sclerosis patients to report adverse events directly to the regulator. One year later the company launched a social media drug safety platform.
To date PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000 different medications – data, the company said, that will now be available to the FDA to supplement its more traditional sources such as FAERS.
The deal adds to its burgeoning pharma client list, to which it recently added AstraZeneca – with which it’s collaborating on real-world data – to a roster than includes Sanofi, Boehringer Ingelheim and Actelion.
