ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework

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

• In part two of an Applied Clinical Trials interview, Inovalon’s Jen Lamppa says large de-identified datasets give sponsors visibility beyond the narrow populations typically captured in traditional trials. She notes these datasets are already being used to inform inclusion criteria, optimize protocols, identify sites with enrollable patients, and better reflect real-world disease demographics. Lamppa adds that the next major opportunity is applying de-identified data directly within regulatory evidence packages.
• Global pharmaceutical production rose sharply in 2025 as manufacturers front-loaded output ahead of anticipated US tariff actions, according to a new Atradius industry report. Output grew 9.1% globally but is expected to slow to 1.6% in 2026 as inventories normalize and tariff effects unwind. While the sector remains structurally resilient, the report cites slower clinical trial setup, regulatory complexity, and rising competition as longer-term constraints on growth.
• The FDA has released a draft of the ICH M4Q(R2) guidance, outlining a globally harmonized structure for quality information in regulatory submissions. The framework standardizes how quality data are organized across Module 2.3 and Module 3, introducing the DMCS model to support digitalization and lifecycle management. FDA is accepting public comments on the draft guidance through March 23, 2026.

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