The collaboration will help the US Food and Drug Administration (FDA) review activities related to risk assessment and risk management in approved drugs post-launch using data provided by the patient group.
Phase IV trials give regulators better insight into the potential adverse events of drugs in a post-market setting, but these studies are only based on a few hundred or thousand patients, PatientsLikeMe President Ben Heywood said.
“We are not running clinical trials,” he told this publication. “This collaboration is about post-market surveillance and understanding more about the data that patients are reporting on our open network, and exploring opportunities to learn more about drug safety.”
Furthermore, he continued, PatientsLikeMe is an open network and “the data come from patients who are reporting on their experiences in the real world, and are not influenced by pharma companies or CROs.”
He continued:“Our members are already syncing FitBit data on their PatientsLikeMe profiles and checking in to tell us how they are doing using PatientsLikeMe’s mobile application. However, today, our members use the website - via mobile and browsers - to report side effects and adverse events.”
The deal was announced at the Drug Information Association’s (DIA) annual meeting in Washington today, with the FDA’s willingness to evaluate new data source described by PatientsLikeMe as an “unprecedented step toward enhancing post-market surveillance and informing regulatory science.”
While the FDA is not paying for this data, Heywood said the project could “lead to future 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.”