Table 2. Changes in Registration Parameters for all 888 Trials Conducted in Ukraine Before and After the Start of the 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 | 490 (55.2) | 132 (14.9) | 47 (5.3) | 85 (9.6) |
| Study statusg | 857 (96.5) | 629 (70.8) | 516 (58.1) | 621 (69.9) |
| Recruitment status | 791 (89.1) | 242 (27.3) | 78 (8.8) | 223 (25.1) |
| Sponsor/collaborators | 215 (24.2) | 39 (4.4) | 18 (2.0) | 30 (3.4) |
| Oversight | 455 (51.2) | 85 (9.6) | 15 (1.7) | 20 (2.3) |
| Study description | 466 (52.5) | 165 (18.6) | 62 (7.0) | 129 (14.5) |
| Conditions | 206 (23.2) | 39 (4.4) | 15 (1.7) | 26 (2.9) |
| Study design | 550 (61.9) | 177 (19.9) | 113 (12.7) | 245 (27.6) |
| Arms and interventions | 458 (51.6) | 146 (16.4) | 61 (6.9) | 108 (12.2) |
| Outcome measuresh | 590 (66.4) | 226 (25.5) | 92 (10.4) | 195 (22.0) |
| Eligibility | 597 (67.2) | 231 (26.0) | 95 (10.7) | 185 (20.8) |
| Contacts and locations | 838 (94.4) | 566 (63.7) | 418 (47.1) | 498 (56.1) |
| IPD sharing | 206 (23.2) | 52 (5.9) | 51 (5.7) | 75 (8.4) |
| References | 193 (21.7) | 51 (5.7) | 38 (4.3) | 67 (7.5) |
| Document section | 80 (9.0) | 39 (4.4) | 18 (2.0) | 46 (5.2) |
| Results | 118 (13.3) | 19 (2.1) | 11 (1.2) | 26 (2.9) |
| Participant flow | 70 (7.9) | 12 (1.4) | 7 (0.8) | 20 (2.3) |
| Baseline characteristics | 76 (8.6) | 12 (1.4) | 10 (1.1) | 20 (2.3) |
| Adverse events | 78 (8.8) | 15 (1.7) | 11 (1.2) | 22 (2.5) |
| More information | 60 (6.8) | 5 (0.6) | 5 (0.6) | 13 (1.5) |
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included: not yet recruiting, recruiting, enrolling by invitation, active, not recruiting, suspended, terminated, or withdrawn or unknown.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, 19 (95% CI, 17-20; IQR, 8-38; range, 0-457).
Median number of study record versions, 3 (95% CI, 2-3; IQR, 0-9.5; range, 0-78).
Median number of study record versions, 1 (95% CI, 1-1; IQR, 0-4; range, 0-76).
Median number of study record versions, 2 (95% CI, 2-3; IQR, 0-8; range, 0-79).
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.