CER Daily Newsfeed

FDA Releases Trove Of Data On Use of Real-World Evidence In Device Clearances

(4/3, Elizabeth Orr, Medtech Insight) reports “...A new report outlines use of real-world evidence in 73 post-2021 device submissions, reflecting the agency’s growing comfort with data drawn from medical records, registries and even data generated by the devices themselves.” Subscription Required

The Use of Real-World Data and Evidence in Clinical Trials

(4/3, Hana Do, Victoria Zhang, Mary Jo Lamberti and Craig Morgan, Applied Clinical Trials) reports “...Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.” Full

Kakao Healthcare, Sanofi Launch AI-Driven RWE Studies in Korea

(4/6, Kim Ji-hye, Korea Biomedical Review) reports “...Specifically, the two companies will jointly conduct real-world evidence (RWE) studies based on medical data...Kakao Healthcare will provide a platform and technology to conduct research based on real-world clinical data. Sanofi will participate in the collaboration by leveraging its AI and digital healthcare capabilities, as well as its medical and scientific expertise.” Full