FDA Guidance Shows How EHR Data Can Help Drug Approvals

As part of its forward-looking initiative to drive greater use of real-world evidence (RWE), the FDA has issued detailed guidance for sponsors and researchers who intend to use electronic health records (EHRs) and medical claims to support drug approvals and post-approval requirements.

The extensive 35-page draft guidance, which applies to all study designs that look to utilize EHR or medical claims data to help show safety or effectiveness, first touches on general considerations, including advice on selecting data sources to maximize data accuracy and completeness.

The guidance makes clear that all studies intending to use and submit such data need to have their protocols and statistical analysis plans submitted prior to initiation.