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12:00 AM
Jun 22, 2015
 |  BioCentury  |  Regulation

Scaling patient-reported data

Why FDA is evaluating patient-reported AE data from PatientsLikeMe

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.

FDA has been collecting adverse event reports from healthcare professionals and drug manufacturers for about 50 years. Its internal systems include the FDA Adverse Event Reporting System (FAERS), which collects data submitted by providers via the MedWatch website, and the Sentinel system, which allows FDA to query electronic health records to identify and monitor postmarket safety concerns.

Two years ago, the agency added a patient-focused adverse event reporting form on MedWatch that enables patients to report safety events directly to FDA.

FAERS has...

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