Multi-regional trials have yet to become the norm

FDA has been pushing for multi-regional clinical trials, especially in Phase III, but the message has yet to fully land with CEOs and their CMOs. Nearly three-quarters of all clinical trials, and half of Phase III trials, are still run in a single country, leaving multi-regional trials far from the default.

BioCentury’s analysis of trials in 2021-2025 in ClinicalTrials.gov found adoption of multi-regional clinical trials remains slow, with 73% of trials across all phases being conducted in a single country. (Trial start dates in those years were used in the analysis)...