Real-World Data: US FDA Sets High Bar For Electronic Health Records, Claims In Applications
Demonstrating that electronic health record and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.
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External Controls: FDA Guidance Provides Clarity But Does Little To Remove Hurdles
Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.
Real-World Data: Sponsors Should Ensure US FDA Access To Patient-Level Data Upon Submission
Informed consent from patients, or institutional review board waivers, are needed to allow bioresearch monitoring inspectors to review source records in a timely fashion without delaying a user fee date, FDA’s Cheryl Grandinetti tells an international good clinical practices workshop.
Real-World Evidence: US FDA Urged To Leverage Prior Validation Work and Regulatory Experience
In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.