ARTICLE SUMMARY:
This month, we spotlight the Medicare agency’s recent draft guidance outlining its expectations for study protocols featuring real-world data.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
“Real-world” sources like registries, electronic health records (EHRs), and insurance claims offer a treasure trove of readily available data to track safety and outcomes and support expanded use and access of medical devices. But many clinicians and statistical experts remain wary of real-world data (RWD), which doesn’t feature the same inherent protections against bias as randomized trials.
Over the past decade FDA has cautiously pushed forward toward greater and greater acceptance of real-world data as a regulatory tool, including recently relying exclusively on RWD to support an expanded device label approval. CMS is now on a similar journey toward expanding its acceptance of RWD in the reimbursement/coverage sphere. This is underscored by the Medicare agency’s January 17 release of a proposed guidance document on “Study Protocols That Use Real-World Data,” our latest doc of the month.
