Table 5 Characteristics and study designs of interventional trials by conditions, 2008–2019
From: Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008–2019
Trials, No.(%) | χ2 | P value | |||||
|---|---|---|---|---|---|---|---|
Infectious (n = 4,863) | Cancer (n = 4,389) | Immune (n = 4,288) | Respiratory (n = 3,855) | ||||
Status | |||||||
Recruiting | Yes | 537(18.3) | 1,183(40.4) | 751(25.6) | 459(15.7) | 505.6 | < 0.001a |
No | 4,326(30.0) | 3,206(22.2) | 3,537(24.5) | 3,396(23.5) | |||
Completed | Yes | 3,064(33.6) | 1,480(16.2) | 2,274(24.9) | 2,313(25.3) | 923.4 | < 0.001b |
No | 1,799(21.8) | 2,909(35.2) | 2,014(24.4) | 1,542(18.7) | |||
Primary purpose | |||||||
Treatment | Yes | 2,179(20.5) | 3,167(29.8) | 3,009(28.3) | 2,272(21.4) | 1,355.7 | < 0.001c |
No | 2,612(47.6) | 1,171(21.3) | 1,194(21.8) | 510(9.3) | |||
Prevention | Yes | 1,822(55.1) | 295(8.9) | 472(14.3) | 716(21.7) | 1,689.5 | < 0.001 |
No | 2,969(21.5) | 4,043(29.3) | 3,731(27.0) | 3,066(22.2) | |||
Missing | 72 | 51 | 85 | 73 | |||
Enrollment | |||||||
1–100 | Yes | 1,590(17.5) | 3,037(33.4) | 2,576(28.3) | 1,902(20.9) | 1,439.5 | < 0.001 |
No | 3,114(40.5) | 1,189(15.5) | 1,569(20.4) | 1,819(23.7) | |||
101–1000 | Yes | 2,267(36.4) | 1,063(17.1) | 1,386(22.2) | 1,515(24.3) | 551.2 | < 0.001 |
No | 2,437(23.1) | 3,163(29.9) | 2,759(26.1) | 2,206(20.9) | |||
>1000 | Yes | 847(58.0) | 126(8.6) | 183(12.5) | 304(20.8) | 784.6 | < 0.001 |
No | 3,857(25.1) | 4,100(26.7) | 3,962(25.8) | 3,417(22.2) | |||
Missing | 159 | 126 | 183 | 304 | |||
Gender | |||||||
Female only | Yes | 283(34.6) | 405(49.5) | 84(10.3) | 46(5.6) | 392.3 | < 0.001d |
No | 4,572(27.6) | 3,973(24.0) | 4,195(25.4) | 3,801(23.0) | |||
Male only | Yes | 71(20.1) | 206(58.2) | 63(17.8) | 14(3.9) | 224.8 | < 0.001 |
No | 4,784(28.1) | 4,172(24.5) | 4,216(24.8) | 3,833(22.5) | |||
Both | 4,501 | 3,767 | 4,132 | 3,787 | |||
Missing | 8 | 11 | 9 | 8 | |||
Interventional model | |||||||
Single-group | Yes | 1,081(18.4) | 2,421(41.2) | 1,517(25.8) | 8,56(14.6) | 1,472.0 | < 0.001e |
No | 3,761(33.0) | 1,898(16.7) | 2,746(24.1) | 2,993(26.3) | |||
Parallel | Yes | 3,506(34.8) | 1,689(16.8) | 2,302(22.8) | 2,586(25.6) | 1,208.9 | < 0.001 |
No | 1,336(18.6) | 2,630(36.6) | 1,961(27.3) | 1,263(17.6) | |||
Missing | 21 | 70 | 25 | 6 | |||
Masking | |||||||
Masking | Yes | 2,166(34.6) | 668(10.7) | 1,511(24.2) | 1,931(30.5) | 1,275.6 | < 0.001 |
No | 2,676(24.2) | 3,678(33.3) | 2,755(25.0) | 1,911(17.5) | |||
Missing | 21 | 43 | 22 | 13 | |||
Allocation | |||||||
Randomized | Yes | 3,511(34.4) | 1,481(14.5) | 2,417(23.6) | 2,810(27.5) | 532.33 | < 0.001 |
No | 516(23.6) | 742(33.9) | 570(26.0) | 362(16.5) | |||
N/A | 816 | 2,095 | 1,258 | 669 | |||
Missing | 20 | 71 | 43 | 14 | |||
Phase | |||||||
3–4 | Yes | 2,017(39.0) | 575(11.2) | 1,229(23.8) | 1,345(26.0) | 1427.8 | < 0.001f |
No | 1,277(20.3) | 2,471(39.3) | 1,683(26.8) | 859(13.7) | |||
NA | 1,569 | 1,343 | 1,376 | 1,651 | |||