ACT Brief: De-Identified RWE Gains Ground, HHS Funding Stabilizes Research, and US Finalizes WHO Exit

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a new Applied Clinical Trials interview, Inovalon’s Jen Lamppa explains that the FDA’s acceptance of real-world evidence without identifiable patient data marks a critical shift for clinical operations teams. She distinguishes anonymized datasets from pseudonymized trial data, noting that de-identified data cannot be re-linked to individuals and carries different privacy and regulatory implications. Lamppa says clinical ops, data management, and biostatistics teams must now consider how anonymized RWE can be integrated more broadly across development workflows and data packages.
• Earlier this week, Congress unveiled a bipartisan funding package proposing $116.8 billion for HHS in 2026, including $48.7 billion for NIH and $9.2 billion for CDC. The bill restores or increases funding for cancer research, public health infrastructure, data modernization, and HIV/AIDS programs after a year marked by proposed cuts and shutdown-related disruptions. The new package could help avert another government shutdown while providing near-term stability for federally funded research.
• The United States’ withdrawal from the World Health Organization is set to be finalized, one year after President Trump issued an executive order initiating the exit. While the required notice period has elapsed, the US still owes approximately $260 million in outstanding fees, raising legal and diplomatic questions. The departure has already triggered major budget cuts at WHO, with the agency planning workforce reductions and scaled-back operations through mid-2026.

That’s all for today’s ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.