Clinical Trial Intelligence
How Fast Are CTIS Approvals and What Delays Phase I Haematology Trials?
19 July 2026
Across 96 Phase I–containing haematology trials, the median CTIS/EU end-to-end decision time was 73 days, while the observed country-specific CTIS Part II interval was substantially longer at 270.5 days. Only 55.2% of end-to-end decisions and 27.3% of Part II country decisions were completed within 90 days. First-in-human status, a four-or-more-country footprint, disease mix and submission month marked the clearest end-to-end differences; country, sponsor profile and CRO use were the clearest Part II separators.
96
Phase I haematology trials
Pooled CTIS/EU cohort
73 days
End-to-end median
SD 49.1 · IQR 22.8–111.3
270.5 days
Part II median
220 country decisions · SD 233.1
44.8%
≥90-day E2E delay
43 of 96 trials
How long does the CTIS/EU end-to-end review take?
The trial-level interval from initial CTIS submission to first authorization had a median of 73 days and a sample standard deviation (SD) of 49.1 days. The middle 50% of trials fell between 22.8 and 111.3 days; the observed range was 6–204 days.
Cumulative share of trials authorized by each interval
30 daysEnd-to-end CTIS/EU
30.2%
60 daysEnd-to-end CTIS/EU
47.9%
90 daysEnd-to-end CTIS/EU
55.2%
120 daysEnd-to-end CTIS/EU
85.4%
180 daysEnd-to-end CTIS/EU
96.9%
55.2%
53 of 96 trials were authorized within 90 days.
96.9%
93 of 96 trials were authorized within 180 days.
Interpretation
A 90-day planning assumption covered only 55.2% of Phase I haematology CTIS submissions. A 120-day allowance covered 85.4%, while 180 days covered 96.9%.
How long does country-specific CTIS Part II take?
Across 220 country decisions, the observed interval from the earliest Part II submission in that country to the latest recorded decision or authorization had a median of 270.5 days and SD of 233.1 days. Country medians ranged from 121.5 days in Austria to 499.0 days in Hungary among countries with at least four decisions.
Country-specific Part II median, SD and 90-day completion
Austrian=4
121.5median days
126.8SD
50.0%≤90 days
Greecen=4
139.5median days
184.1SD
25.0%≤90 days
Finlandn=2
166.5median days
160.5SD
50.0%≤90 days
Bulgarian=3
195.0median days
210.7SD
33.3%≤90 days
Belgiumn=12
201.0median days
199.6SD
33.3%≤90 days
Czechian=4
204.5median days
180.1SD
25.0%≤90 days
Francen=46
237.5median days
240.4SD
28.3%≤90 days
Norwayn=4
238.0median days
141.4SD
25.0%≤90 days
Romanian=1
242.0median days
—SD
0.0%≤90 days
Swedenn=9
265.0median days
216.8SD
11.1%≤90 days
Netherlandsn=14
270.5median days
228.9SD
21.4%≤90 days
Denmarkn=5
280.0median days
160.0SD
20.0%≤90 days
Spainn=40
295.5median days
243.7SD
30.0%≤90 days
Italyn=33
325.0median days
259.0SD
30.3%≤90 days
Polandn=13
380.0median days
228.5SD
23.1%≤90 days
Germanyn=22
401.5median days
261.8SD
27.3%≤90 days
Hungaryn=4
499.0median days
168.1SD
0.0%≤90 days
Interpretation
Among higher-volume countries (n≥10), Belgium had the shortest median Part II interval at 201.0 days, followed by France at 237.5 days. Germany had the longest at 401.5 days, followed by Poland at 380.0 days and Italy at 325.0 days.
What percentage of decisions finish within 30, 60, 90 and 180 days?
End-to-end CTIS/EU authorization accumulated much faster than country-specific Part II. By 90 days, 53 of 96 trials (55.2%) had an initial authorization, compared with 60 of 220 country Part II decisions (27.3%).
Delay thresholds
Two-month-or-longer delay occurred in 53 of 96 end-to-end reviews (55.2%) and 167 of 220 Part II decisions (75.9%). Three-month-or-longer delay occurred in 43 of 96 end-to-end reviews (44.8%) and 160 of 220 Part II decisions (72.7%).
Which factors mark faster or slower end-to-end CTIS approval?
The strongest descriptive differences were associated with first-in-human status, number of participating countries, disease group, modality mix and month of initial EU submission. These are cohort associations, not causal effects.
Shorter median
21 days
Multiple myeloma
n=13; 61.5% were below the 73-day overall median and 3/13 (23.1%) reached ≥90 days.
Shorter median
29 days
Cell or gene therapy
n=19; 63.2% were below the overall median and 7/19 (36.8%) reached ≥90 days.
Higher delay rate
108 days
First-in-human trials
9/13 (69.2%) reached ≥90 days versus 21/56 (37.5%) among non-first-in-human trials.
Wider footprint
103 days
Four or more countries
13/22 (59.1%) reached ≥90 days versus 23/59 (39.0%) for single-country trials; Spearman ρ=+0.21.
Disease pattern
111–114 days
Non-malignant and MDS/MPN
≥90-day delay occurred in 9/11 (81.8%) non-malignant trials and 4/6 (66.7%) MDS/MPN trials.
Trial mix pattern
56 days
Combination treatment
n=49 versus 97 days for monotherapy (n=46); ≥90-day delay was 34.7% versus 54.3%.
Initial CTIS/EU submission month: median end-to-end days
Jan
46.5
median days · n=6
16.7% ≥90d
Feb
95.0
median days · n=11
54.5% ≥90d
Mar
105.5
median days · n=4
100.0% ≥90d
Apr
50.5
median days · n=4
0.0% ≥90d
May
55.5
median days · n=6
33.3% ≥90d
Jun
33.0
median days · n=1
0.0% ≥90d
Jul
98.5
median days · n=14
57.1% ≥90d
Aug
38.5
median days · n=12
33.3% ≥90d
Sep
29.0
median days · n=13
30.8% ≥90d
Oct
82.0
median days · n=11
45.5% ≥90d
Nov
119.0
median days · n=5
60.0% ≥90d
Dec
119.0
median days · n=9
66.7% ≥90d
Interpretation
First-in-human trials had nearly twice the ≥90-day delay rate of non-first-in-human trials (69.2% vs 37.5%). Multicountry complexity also moved in the expected direction: the median increased from 60 days for one-country submissions to 103 days for four or more countries.
What correlates with substantial CTIS Part II delay?
To avoid overweighting multicountry trials, non-country factor comparisons used one median Part II value per trial. Sponsor profile and CRO involvement showed the clearest group separation; country and Part II submission month remained major operational separators at the decision level.
Sponsor profile
203.5 days
Non-pharmaceutical sponsor
n=46; 28/46 (60.9%) had a trial-level Part II median ≥90 days.
Sponsor profile
314 days
Pharmaceutical sponsor
n=50; 39/50 (78.0%) had a trial-level Part II median ≥90 days.
Operational model
224 days
No CRO recorded
n=69; 45/69 (65.2%) reached ≥90 days at trial-median level.
Operational model
342 days
CRO recorded
n=27; 22/27 (81.5%) reached ≥90 days. This likely reflects more complex programs rather than a CRO effect itself.
Site footprint
174 days
One to three sites
n=32; 19/32 (59.4%) reached ≥90 days.
Site footprint
342 days
Four to ten sites
n=27; 21/27 (77.8%) reached ≥90 days; 11+ sites had a 268-day median.
Part II submission month: median country-decision interval
Jan
295.0
median days · n=25
72.0% ≥90d
Feb
470.5
median days · n=18
88.9% ≥90d
Mar
150.5
median days · n=16
68.8% ≥90d
Apr
344.0
median days · n=24
95.8% ≥90d
May
263.5
median days · n=14
85.7% ≥90d
Jun
523.5
median days · n=26
73.1% ≥90d
Jul
495.0
median days · n=10
80.0% ≥90d
Aug
253.5
median days · n=18
72.2% ≥90d
Sep
267.5
median days · n=20
80.0% ≥90d
Oct
69.5
median days · n=34
47.1% ≥90d
Nov
111.0
median days · n=7
57.1% ≥90d
Dec
162.0
median days · n=8
50.0% ≥90d
Interpretation
The Part II signal was dominated by country and timing of the country submission. Sponsor and CRO differences persisted descriptively, but both are likely proxies for program scale, multinational complexity and vendor intensity.
Which tested factors did not show a consistent timing signal?
Several plausible complexity measures had weak or non-monotonic relationships with review time. Their correlations were too small or inconsistent to treat as reliable planning levers in this cohort.
Spearman correlation with review duration
| Factor | End-to-end ρ | Trial-level Part II ρ | Reading |
|---|
| Number of countries | +0.21 | +0.16 | Longer |
| Total sites | −0.01 | +0.17 | Weak |
| Planned sample size | −0.14 | +0.16 | Mixed |
| Total endpoint count | +0.04 | −0.04 | None |
| Eligibility-criteria count | +0.03 | −0.10 | None |
| Recruitment window | −0.42 | +0.09 | Non-causal pattern |
Interpretation
Document volume proxies—endpoint and eligibility counts—were essentially uncorrelated with timing. The more reproducible operational signal was geographic breadth rather than the raw number of sites or planned participants.
What should EU submission teams plan for?
Base E2E plan
120 days
Covers 85.4%
82 of 96 initial CTIS authorizations were completed by this point.
High-confidence E2E plan
180 days
Covers 96.9%
93 of 96 initial authorizations were completed by this point.
Country Part II
365 days
Still covers only 63.2%
139 of 220 country decisions were completed within one year.
Extra buffer
+43 days
Four-or-more-country E2E uplift
Median 103 days versus 60 days for single-country submissions.
Operational conclusion
Use separate clocks: a trial-level CTIS/EU authorization clock and a country-specific Part II clock. For first-in-human or broad multicountry programs, schedule above the 73-day cohort median; for Part II, use country-specific benchmarks rather than applying the end-to-end median to individual countries.
Definitions and analytical frame. End-to-end review is the number of days from initial CTIS submission to first CTIS authorization and is reported only at trial level. CTIS Part II is country-specific and is measured from the earliest recorded Part II submission in a country to the latest recorded country decision or authorization. SD is the sample standard deviation. The cohort includes Phase I and Phase I/II haematology trials. Factor comparisons are exploratory associations; calendar year was not included in the analysis.