Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Monday at the Bipartisan Policy Center conference touted the potential of real-world evidence, saying the agency will make the integration of real-world data and RWE a “key priority for the FDA.”
The agency in December released a framework that outlined the agency’s plans for advancing the use of RWE in regulatory environments moving forward.
“RWD and RWE are already being used extensively for postmarket monitoring of the safety of products during their use in real world settings,” Gottlieb said Monday. ” … Our use of RWD and RWE … eliminated the need for postmarketing studies on nine potential safety issues involving five products, making our post-market evaluation of safety timelier and more effective.”
Gottlieb said the increasing rate and volume of RWD making its way to the agency has opened the door to utilizing innovative technologies, including natural language processing and deep learning, to streamline development programs.
According to a report by the Regulatory Affairs Professional Society, Gottlieb also discussed using new technology to change up where clinical trials take place for a more decentralized approach.
“To support the development and adoption of decentralized trials, the FDA established a formal working group on decentralized trials, and we’re working towards writing a guidance document to outline our approach,” Gottlieb said.
To read Gottlieb’s full remarks on the FDA’s website, click here.
