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.
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included: not yet recruiting, recruiting, enrolling by invitation, active, not recruiting, suspended, terminated, or withdrawn or unknown.
Trials with 1 or more study record versions with changed registration item.
Median number of study record versions, 1 (95% CI, 1-2; IQR, 0-2; range, 0-47).
Median number of study record versions, 0 (95% CI, 0-0; IQR, 0-0; range, 0-3).
Median number of study record versions, 0 (95% CI, 0-0; IQR, 0-0; range, 0-1).
Median number of study record versions, 0 (95% CI, 0-1; IQR, 0-1; range, 0-2).
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.
Refers both to protocol and study results information.