Clinical Trial Intelligence
How Fast Are Phase I Nephrology CTIS Reviews and What Shapes Timing?
20 July 2026
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.
77 days
Median EU CTIS end to end
7 trial-level approvals · SD 40.6
67 days
Median country Part II
10 country-trial records · SD 185.0
117 vs 40
Multi- vs one-country
77-day median difference
How long does EU CTIS approval take end to end?
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.
Cumulative authorization rate
Within 30 days
2/7 · 28.6%
Within 60 days
3/7 · 42.9%
Within 90 days
4/7 · 57.1%
Within 120 days
7/7 · 100.0%
Initial EU CTIS submission → first authorization; n=7 trials
Distribution
18 d
Fastest
Single-country transplant trial
119 d
Longest
Two-country CKD trial
73 d
Mean
Below the 77-day median
40.6 d
SD
Population SD across trials
Interpretation
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.
How long does country-specific CTIS Part II take?
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.
Cumulative Part II completion
Within 30 days
3/10 · 30.0%
Within 60 days
5/10 · 50.0%
Within 90 days
6/10 · 60.0%
Within 180 days
6/10 · 60.0%
Within 365 days
9/10 · 90.0%
Country-specific CTIS Part II submission → latest country decision; n=10 records
Part II by country
Denmark
1
11 d
0 d
11–11 d
Romania
1
58 d
0 d
58–58 d
Netherlands
2
142.5 d
141.5 d
1–284 d
France
2
179.5 d
154.5 d
25–334 d
Germany
3
288 d
209.6 d
76–587 d
Population SD; one-record countries show 0-day observed SD
Interpretation
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.
Which factors tracked with faster or delayed EU CTIS approval?
“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.
Geographic scope
1 country40 d
3/5 faster than median; 1/5 ≥90 d
2–3 countries117 d
0/2 faster than median; 2/2 ≥90 d
Trial sites
1 site40 d
Median across 5 trials
3 sites117 d
Both trials ≥90 d; ρ=0.79
Sponsor setting
Hospital-led29 d
2/3 faster than median; 0/3 ≥90 d
Pharma-led114 d
1/4 faster than median; 3/4 ≥90 d
Therapy structure
Cell therapy29 d
2/3 faster than median; 0/3 ≥90 d
Other/unspecified114 d
3/4 ≥90 d
Continuous timing correlations
Total trial sites
Spearman ρ = 0.79
Number of countries
Spearman ρ = 0.76
Target sample size
Spearman ρ = 0.43
Recruitment-window length
|ρ| = 0.11 · no clear signal
Positive ρ indicates longer review with increasing factor value; n=7 trials
Interpretation
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.
How did multi-country submissions affect country Part II?
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%).
Country Part II by trial footprint
Single-country trials
25 d
4/5 below Part II median · 1/5 ≥90 d
Multi-country trials
284 d
1/5 below Part II median · 3/5 ≥90 d
Association between country count and Part II time: Spearman ρ=0.59; n=10 records
Interpretation
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.
Did submission month show a repeatable pattern?
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.
End-to-end by submission month
Part II by submission month
Interpretation
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.
What should teams plan for?
120 d
Use a four-month end-to-end authorization buffer
It covered 7/7 EU CTIS approvals in this cohort, compared with 4/7 at 90 days.
77 d
Treat each added country as an upstream schedule decision
Multi-country submissions had a 77-day higher median than one-country submissions.
67 d
Budget country Part II separately
The country-level median masks a 1–587-day range; country selection and sequencing require separate assumptions.
Definitions: CTIS = Clinical Trials Information System. End-to-end = initial EU CTIS submission to first authorization. Part II = country-specific ethical, site, participant-information, and local-feasibility assessment. SD = population standard deviation across observed records. Associations are descriptive and not causal.