Scaling patient-reported data

By teaming up with PatientsLikeMe Inc., FDA hopes to learn whether data reported by patients via social media can fill in the gaps left by its existing adverse event reporting systems, including information on the causal relationship between an adverse event and a drug.

PatientsLikeMe thinks the project could later be expanded to help the agency incorporate similar patient-reported data into the evaluation and design of REMS, and to increase participation in FDA's patient-focused drug development initiative to improve understanding of how different patient populations weigh benefit and risk...