Table III.
COVID-19 research at sites, impact on pediatric clinical research, and mitigation strategies used to ensure continuity of clinical trials
| Variables | All sites, % (n/N) | Clusters |
Taskforce |
||||
|---|---|---|---|---|---|---|---|
| EDC, % (n/N) | LDC, % (n/N) | P | Negative, % (n/N) | Positive, % (n/N) | P | ||
| COVID-19 research at sites | |||||||
| Staff redirection to COVID-19 research | 44 (22/50) | 50 (13/26) | 33 (6/18) | .36 | 45 (15/33) | 41 (7/17) | 1.0 |
| Staff involvement in pediatric projects | 76 (37/49) | 80 (20/25) | 67 (12/18) | .48 | 82 (27/33) | 63 (10/16) | .17 |
| Impact on clinical research | |||||||
| Initiation visit cancellations | 66 (31/47) | 68 (17/25) | 71 (12/17) | 1.0 | 72 (23/32) | 53 (8/15) | .32 |
| Feasibility process impacted | 54 (25/46) | 63 (15/24) | 53 (9/17) | .75 | 56 (18/32) | 50 (7/14) | .75 |
| Less research visits on site | 37 (18/49) | 44 (11/25) | 22 (4/18) | .20 | 39 (13/33) | 31 (5/16) | .75 |
| Mitigation strategies∗ | |||||||
| Visits by phone call | 86 (42/49) (100) | 92 (24/26) | 78 (14/18) | .21 | 88 (28/32) | 82 (14/17) | .68 |
| Visits by home nurse intervention | 22 (11/49) (57) | 27 (7/26) | 11 (2/18) | .27 | 19 (6/32) | 29 (5/17) | .48 |
| Biological safety assessments at the patient's home or a nearby laboratory | 23 (9/39) (36) | 30 (7/23) | 17 (2/12) | .45 | 15 (4/26) | 38 (5/13) | .13 |
| Questionnaires and standard tests by telephone or videoconference | 72 (28/39) (79) | 65 (15/23) | 75 (9/12) | .71 | 77 (20/26) | 62 (8/13) | .45 |
| Sending study drug to the patient's home | 26 (10/39) (29) | 43 (10/23) | 0 (0/12) | <.01 | 15 (4/26) | 46 (6/13) | .06 |
EDC, early detecting cluster; LCD, late detecting cluster.
Population data were obtained from the World Bank (World Development Indicators, 2020). EDC, early detecting cluster (n = 7 countries); LCD, late detecting cluster (n = 11 countries).
∗
Percentages of countries in Figure 1 are also shown in parentheses for mitigation strategies.