Across 147 Phase I or Phase I/II pediatric trials, the median EU Clinical Trials Information System (CTIS) submission-to-authorization timeline was 77 days with a 49.9-day standard deviation. 79/147 trials (53.7%) were authorized within 90 days. Country-specific CTIS Part II timelines were substantially more dispersed, with a 254-day median and 259.7-day standard deviation across 393 country observations.
The median end-to-end interval from initial EU CTIS submission to first authorization was 77 days. Only 38/147 trials (25.9%) cleared within 30 days, while 119/147 (81.0%) cleared within 120 days.
The largest gain occurs between 90 and 120 days: the cumulative authorization rate rises from 53.7% to 81.0%, a 27.2-percentage-point increase.
Across 393 country-specific Part II observations in 18 countries, Austria had the lowest median at 24 days, followed by Sweden at 49 days and Norway at 89 days. Greece had the highest median at 448 days.
Country medians vary 18.7-fold, from 24 to 448 days. Large SDs in major countries, including Spain (284.8) and Germany (263.3), indicate that country choice alone does not make Part II timing predictable.
133/393 Part II observations (33.8%) were completed within 60 days and 148/393 (37.7%) within 90 days. Even at 365 days, the cumulative share was 63.4%.
Cell therapy had the shortest modality median at 42 days, while gene therapy had a 109-day median. Solid tumour indications had a 34-day median, compared with 106.5 days for acute lymphoblastic leukemia.
The strongest faster pattern was solid tumour indications: 15/20 (75.0%) were below the median and only 4/20 (20.0%) reached 90 days. Acute lymphoblastic leukemia showed the reverse pattern, with 15/22 (68.2%) at 90 days or longer.
First-in-human status was the clearest design-level delay marker: 13/18 trials (72.2%) required at least 90 days. Dose-escalation trials had a 92-day median, compared with 53 days for trials without dose escalation.
Only 4/18 first-in-human trials (22.2%) were faster than the median, versus 69/129 (53.5%) among other trials. These are associations and should be treated as planning signals rather than causal effects.
February submissions had a 31-day median and January submissions a 25-day median. December submissions had the longest median at 119 days, with 14/19 trials (73.7%) taking at least 90 days; November followed at 116 days with 6/9 trials (66.7%) at 90 days or longer.
The December median was 94 days longer than January and 88 days longer than February. For planning, late-calendar submissions carried the clearest observed risk of crossing the 90-day threshold.
Trial footprint was not a strong linear driver. The Spearman correlation between end-to-end days and country count was 0.11; for site count it was 0.03. Participant count showed a small negative correlation of -0.18.
Operational scale alone did not explain delay: country count and site count both had correlations close to zero. Trial type, first-in-human status, disease, modality, and submission month were more informative planning signals.
EU CTIS end to end: initial CTIS submission date to first CTIS authorization date at trial level.
CTIS Part II: country-specific interval from earliest Part II submission to latest decision or authorization in that country.
Fast: shorter than the cohort median of 77 days.
SD: sample standard deviation; ρ: Spearman rank correlation.