To help fulfill the requirements of the 21st Century Cures Act by accelerating medical product development and fostering innovation and advances in medicine, FDA recently created a framework for evaluating the use of real-world evidence. The framework is intended to help evaluate trials that use real-world data for the creation of real-world evidence.
- Real-world data: routinely collected information about a person’s health status in the electronic health record, claims, registries, and other sources, including patient-generated sources.
- Real-world evidence: reliable, clinical information derived from real-world data about risks, benefits, and burdens of therapies.
This framework will apply to various pragmatic clinical trials embedded in health care systems and conducted as part of routine care (and will not apply to more traditional clinical trials conducted parallel to care).
Three main considerations are included in the framework:
- Will the real-world data be fit for use (do they reliably and adequately represent the concept)?
- Will the evidence generated by the trial provide adequate evidence to help answer regulatory questions?
- Will the conduct of the study meet FDA regulatory requirements?