Covid-19 Helps Advance RWE at FDA: Attorneys
The Covid-19 emergency has had the unintended consequence of cementing the use of real-world evidence (RWE)and real-world data (RWD) in product submissions at FDA. Writing in a Med Device Online 11/4 article, Hogan Lovells attorneys Kelliann Payne, Blake Wilson, and Megana Sankaran predict RWE will continue to play a bigger role in the regulatory approval processes.
RWE use during the pandemic, particularly to support emergency use authorization of diagnostic tests, has “demonstrated its utility in accelerating clinical development and ameliorating risks associated with traditional clinical trials (e.g., in-person trial visits), while maintaining the integrity of the clinical investigation,” the authors contend. “By forcing the FDA to become comfortable with the use of RWD in order to authorize Covid-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of RWE it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE. However, only time will tell if the FDA’s moderation during these exigent circumstances will open the door to more productive discussions on how RWE can develop into a mainstay for medical product development.”
Despite CDRH guidance articulating the Center’s willingness to evaluate RWE to meet regulatory requirements, success has been mixed in practice, according to the authors. “Specifically, the FDA has requested sponsors of medical device marketing applications to demonstrate that RWD is as robust as clinical trial data, which is often impractical,” they write. “Specifically, the FDA has expressed concerns with sub-optimal data quality and reliability, lack of follow-up data, and selection bias. In addition, the FDA has commented that a single source of RWD may not be sufficient, and that multiple data sources may be needed. This, too, represents the agency’s view that RWD should have the same ‘elements’ as data generated from a multicenter, prospective clinical trial.”
The National Evaluation System for Health Technology Coordinating Center has developed a RWE protocol template that includes guiding principles to help bring RWD collection in line with FDA’s standards, the authors note. “The template focuses on prespecifying characteristics of the data collection (e.g., patient population, monitoring plan, statistical analyses) and providing more context around the process for conducting the investigation (e.g., patient selection method, assessments procedures, etc.),” they write.
And businesses like Flatiron Health are helping to both collect and present RWE in a way that addresses FDA’s concerns with data validity, according to the authors. “The entry of RWE businesses means that it will be easier for sponsors to assess the costs and likely benefits of seeking new or expanded indications using RWE, which should improve the tolerance for uncertainties that remain in this regulatory option,” they write.