The US Food and Drug Administration (FDA) is removing a limitation on the use of real-world evidence (RWE), clearing the way for de-identified data to be used for medical device submissions.
Stating that it plans to consider a similar move for drugs and biologics applications, the FDA highlighted that while RWE has been promoted as an advance in regulatory policy, prior agency expectations have meant that most RWE could not be considered in product applications.
The FDA has traditionally mandated that any RWE submitted to the agency include private, confidential information at the individual patient level. According to the agency, this approach makes it ‘impractical’ to use most large databases with valuable macro-level data.
The regulator said that changing the historic FDA policy on RWE requirements will lead to the use of de-identified databases containing millions of patient records. These include the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, hospital systems and insurance claims databases, and electronic health record (EHR) networks.
Databases like the aforementioned have grown exponentially yet have remained limited for use under the previous policy promulgated by the agency, despite the fact that they track patient outcomes across diverse populations and real-world treatment settings and offer insights that traditional clinical trials cannot capture, according to the FDA.
RWE can also help researchers identify the most relevant variables, thereby saving costs and time in data collection.
FDA commissioner Marty Makary commented: "We're removing unnecessary barriers that have prevented us from using powerful RWE to get life-changing treatments to patients faster.
"This common-sense reform will unlock access to vast databases like cancer and cystic fibrosis registries that contain critical insights about how treatments work in the real world."
In an announcement about the plans, the FDA said that reviewers will now consider the strength of submitted RWE on an application-by-application basis and that its new guidance will apply to "certain" types of medical device submissions.
Medical Device Network has reached out to the FDA to clarify what, if any, types of medical device submissions will be exempt from the past necessitate to include identifiable patient data.
