Table 2 Characteristics of interventional trials by funding sources a and funding sites, 2008–2019
From: Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008–2019
Trials, No.(%) | ||||||
|---|---|---|---|---|---|---|
Industry-funded | NIH-funded | Other | ||||
Single-site (n = 2,786) | Multisite (n = 5,081) | Single-site (n = 1,656) | Multisite (n = 985) | Single-site (n = 17,734) | Multisite (n = 3,660) | |
Status | ||||||
Not yet recruiting | 51(1.8) | 27(0.5) | 30(1.8) | 12(1.2) | 369(2.1) | 85(2.3) |
Recruiting | 316(11.3) | 718(14.1) | 377(22.8) | 204(20.7) | 3,040(17.1) | 902(24.6) |
Enrolling by invitation | 33(1.2) | 57(1.1) | 30(1.8) | 12(1.2) | 239(1.3) | 43(1.2) |
Active, not Recruiting | 148(5.3) | 502(9.9) | 190(11.5) | 169(17.2) | 894(5.0) | 316(8.6) |
Completed | 1,692(60.7) | 3,125(61.5) | 853(51.5) | 499(50.7) | 9,053(51.0) | 1,694(46.3) |
Suspended | 12(0.4) | 29(0.6) | 19(1.1) | 14(1.4) | 108(0.6) | 23(0.6) |
Terminated | 191(6.9) | 427(8.4) | 85(5.1) | 43(4.4) | 740(4.2) | 158(4.3) |
Withdrawn | 76(2.7) | 51(1.0) | 30(1.8) | 9(0.9) | 435(2.5) | 43(1.2) |
Unknown status | 267(9.6) | 145(2.9) | 42(2.5) | 23(2.3) | 2,856(16.1) | 396(10.8) |
Primary purpose | ||||||
Treatment | 1,718(61.7) | 3,867(76.1) | 832(50.2) | 646(65.6) | 9,602(55.6) | 2,096(58.4) |
Prevention | 458(16.4) | 689(13.6) | 363(21.9) | 191(19.4) | 3,008(17.4) | 617(17.2) |
Diagnostic | 113(4.1) | 80(1.6) | 75(4.5) | 19(1.9) | 996(5.8) | 181(5.0) |
Other b | 393(14.1) | 325(6.4) | 364(22.0) | 120(12.5) | 3,656(21.2) | 693(19.3) |
Missing | 104(3.7) | 118(2.3) | 23(1.4) | 6(0.6) | 472(2.7) | 73(2.0) |
Intervention c | ||||||
Drug | 1,281(42.1) | 3,356(66.0) | 463(27.8) | 490(49.4) | 5,189(29.3) | 1,243(34.0) |
Behavioral | 132(4.5) | 38(0.8) | 735(44.5) | 229(23.6) | 3,583(20.2) | 758(20.7) |
Device | 468(15.3) | 455(8.9) | 86(5.2) | 56(5.8) | 2,342(13.2) | 386(10.5) |
Biological | 450(14.7) | 1,020(20.0) | 143(8.7) | 130(13.5) | 784(4.4) | 236(6.4) |
Other d | 692(23.2) | 646(13.2) | 587(36.4) | 384(40.8) | 7,643(44.2) | 1,435(40.3) |
Enrollment | ||||||
1–100 | 1,691(60.9) | 2,487(49.0) | 930(56.2) | 427(43.4) | 11,088(62.8) | 1,692(47.0) |
101–1,000 | 881(31.7) | 2,208(43.5) | 568(34.3) | 454(46.1) | 5,105(28.9) | 1,491(41.4) |
>1,000 | 134(4.8) | 330(6.6) | 126(7.6) | 95(9.6) | 1,022(5.8) | 417(11.6) |
Missing | 70(2.5) | 50(1.0) | 30(1.8) | 9(0.9) | 440(2.5) | 42(1.2) |
Interventional model | ||||||
Single-group | 1,077(38.7) | 1,892(37.2) | 467(28.2) | 275(27.9) | 4,695(26.5) | 888(24.3) |
Parallel | 1,455(52.2) | 2,820(55.5) | 1,000(60.4) | 630(64.0) | 11,289(63.7) | 2,387(65.2) |
Other e | 242(8,7) | 325(6.4) | 181(11.0) | 79(8.0) | 1,660(9.4) | 354(9.7) |
Missing | 12(0.4) | 44(0.9) | 8(0.5) | 1(0.1) | 90(0.5) | 31(0.8) |
Masking | ||||||
Non-masking | 1,596(57.6) | 2,939(58.0) | 988(59.7) | 606(61.5) | 9,859(55.9) | 2,213(60.9) |
Masking | 1,177(42.4) | 2,126(42.0) | 657(40.3) | 375(38.5) | 7,763(44.1) | 1,418(39.1) |
Missing | 13(0.5) | 16(0.3) | 11(0.7) | 4(0.4) | 112(0.6) | 29(0.8) |
Allocation | ||||||
Randomized | 1,596(57.6) | 2,758(54.9) | 1,094(66.1) | 647(65.7) | 12,085(68.6) | 2,517(69.4) |
Non-randomized | 283(10.2) | 713(14.2) | 164(9.9) | 104(10.6) | 1,766(10.0) | 381(10.5) |
N/A | 889(32.2) | 1,550(30.8) | 385(23.2) | 229(23.2) | 3,756(21.3) | 728(20.1) |
Missing | 18(0.6) | 60(1.2) | 13(0.8) | 5(0.5) | 127(0.7) | 34(0.9) |
Phase | ||||||
0–2 | 1,004(36.1) | 1,941(38.3) | 554(33.5) | 455(46.2) | 3,467(19.6) | 893(24.4) |
3–4 | 820(29.3) | 2,482(48.7) | 127(7.6) | 193(19.6) | 2,697(15.2) | 702(19.2) |
N/A | 962(34.6) | 668(13.0) | 975(58.9) | 337(34.2) | 11,570(65.2) | 2,065(56.4) |