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. 2023 Jun 26;6(6):e2320202. doi: 10.1001/jamanetworkopen.2023.20202

Table 4. Changes in Registration Parameters for 46 Trials With Sites Only in Ukraine Before and After the Start of Russian Invasiona.

Registration item Changes in observation period, No. (%)b
Before the war in Ukraine After the war started
First version, February 24, 2022c February 24, 2021-February 24, 2022d February 24, 2022-July 25, 2022e February 24, 2022-February 24, 2023f
Study identification 3 (6.5) 1 (2.2) 1 (2.2) 1 (2.2)
Study statusg 31 (67.4) 9 (19.6) 11 (23.9) 18 (39.1)
Recruitment status 24 (52.2) 6 (13.0) 3 (6.5) 9 (19.6)
Sponsor/collaborators 11 (23.9) 2 (4.3) 1 (2.2) 1 (2.2)
Oversight 8 (17.4) 1 (2.2) 1 (2.2) 3 (6.5)
Study description 12 (26.1) 2 (4.3) 1 (2.2) 1 (2.2)
Conditions 3 (6.5) 1 (2.2) 0 0
Study design 9 (19.6) 2 (4.3) 3 (6.5) 10 (21.7)
Arms and interventions 8 (17.4) 2 (4.3) 1 (2.2) 2 (4.3)
Outcome measuresh 12 (26.1) 2 (4.3) 1 (2.2) 2 (4.3)
Eligibility 8 (17.4) 2 (4.3) 1 (2.2) 3 (6.5)
Contacts and locations 16 (34.8) 4 (8.7) 4 (8.7) 8 (17.4)
IPD sharing 1 (2.2) 1 (2.2) 0 0
References 4 (8.7) 0 2 (4.3) 1 (2.2)
Document section 0 0 0 0
Results 0 0 0 0
Participant flow 0 0 0 0
Baseline characteristics 0 0 0 0
Adverse events 0 0 0 0
More information 0 0 0 0

Abbreviation: IPD, individual participant data.

a

Trials with any noncompleted status on July 25, 2022, were included: not yet recruiting, recruiting, enrolling by invitation, active, not recruiting, suspended, terminated, or withdrawn or unknown.

b

Trials with 1 or more study record versions with changed registration item.

c

Median number of study record versions, 1 (95% CI, 1-2; IQR, 0-2; range, 0-47).

d

Median number of study record versions, 0 (95% CI, 0-0; IQR, 0-0; range, 0-3).

e

Median number of study record versions, 0 (95% CI, 0-0; IQR, 0-0; range, 0-1).

f

Median number of study record versions, 0 (95% CI, 0-1; IQR, 0-1; range, 0-2).

g

Because study status also includes the date when the last update was posted, this parameter was changed in all trials with 1 or more study record versions noted in the ClinicalTrials.gov archive site.

h

Refers both to protocol and study results information.