Across 7 European Phase I or Phase I/II nephrology trials submitted through the EU Clinical Trials Information System (CTIS), median end-to-end review time was 77 days (SD 40.6), while the 10 country-specific CTIS Part II records had a median of 67 days (SD 185.0). Geographic complexity was the clearest timing signal: one-country submissions had a 40-day median, compared with 117 days for multi-country submissions.
End-to-end time—from initial EU CTIS submission to first authorization—ranged from 18 to 119 days. Four of 7 trials (57.1%) were authorized within 90 days, and all 7 were authorized within 120 days.
A 90-day planning assumption covered only 57.1% of observed Phase I nephrology EU submissions. A 120-day authorization buffer covered the full cohort.
Country-specific Part II processing ranged from 1 to 587 days. Five of 10 records (50.0%) were completed within 60 days and 6 of 10 (60.0%) within 90 days. The median remained 67 days despite one 587-day record, while the SD rose to 185.0 days.
Country performance was highly heterogeneous. Denmark, Italy, and Romania were at or below 58 days in the observed records, while Germany had a 288-day median across three records. CTIS Part II is country-specific and should not be treated as a country-level decomposition of the trial-wide end-to-end decision.
“Faster” means below the 77-day cohort median; substantial delay means at least 60 days, with severe delay defined as at least 90 days. The strongest signals were geographic scale, site count, sponsor setting, and the disease/modality cluster.
The most actionable upstream choice was submission footprint. Trials with three sites had a 117-day median and both exceeded 90 days, versus a 40-day median for one-site trials. Sponsor and modality patterns are descriptive and strongly confounded by the underlying trial types.
Part II records belonging to multi-country trials had a 284-day median, compared with 25 days for records from single-country trials. Three of 5 multi-country records (60.0%) exceeded 90 days versus 1 of 5 single-country records (20.0%).
The Part II signal reinforces the trial-level result: operational coordination across countries, rather than the number of sites inside an individual country, was the more consistent delay marker.
Month-of-year patterns were mixed and less stable than geographic complexity. October had three end-to-end observations with a 113-day median, while the other months each had one observation. For Part II, December records had a 46.5-day median and April records 286 days, but each contained only two records.
Submission month should be treated as a secondary planning signal. The repeatable evidence favored reducing country and site complexity rather than selecting a specific month.
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