From: Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008–2019
Trials, No.(%) | Z value a | P value | ||||||
---|---|---|---|---|---|---|---|---|
All 2008–2019 (n = 36,136) | 2008–2010 (n = 7,029) | 2011–2013 (n = 7,486) | 2014–2016 (n = 9,883) | 2017–2019 (n = 11,738) | ||||
Primary purpose | ||||||||
Treatment | Yes | 21,126(60.0) | 4,608(68.1) | 4,476(62.7) | 5,614(58.7) | 6,428(54.8) | −16.12 | < 0.001 |
no | 14,074(40.0) | 2,160(31.9) | 2,658(37.3) | 3,951(41.3) | 5,305(45.2) | |||
Prevention | Yes | 6,110(17.4) | 1,227(18.1) | 1,376(19.3) | 1,514(15.8) | 1,962(16.7) | −3.57 | < 0.001 |
no | 29,090(82.6) | 5,541(81.9) | 5,758(80.7) | 805(84.2) | 9,771(83.3) | |||
Missing | Yes | 936(2.6) | 261(3.7) | 352(4.7) | 318(3.2) | 5(0.0) | −15.90 | < 0.001 |
no | 35,200(97.4) | 6,768(96.3) | 7,134(95.3) | 9,565(96.8) | 11,733(100.0) | |||
Intervention | ||||||||
Drug | Yes | 13,348(36.9) | 3,427(48.8) | 3,066(41.0) | 3,457(35.0) | 3,398(28.9) | −24.68 | < 0.001 |
no | 22,788(63.1) | 3,602(51.2) | 4,420(59.0) | 6,426(65.0) | 8,340(71.1) | |||
Behavioral | Yes | 6,194(17.1) | 889(12.6) | 1,171(15.6) | 1,739(17.6) | 2,395(20.4) | 12.28 | < 0.001 |
no | 29,942(82.9) | 6,140(87.4) | 6,315(84.4) | 8,144(82.4) | 9,343(79.6) | |||
Enrollment | ||||||||
1–100 | Yes | 20,676(58.9) | 3,820(56.8) | 4,158(58.0) | 5,758(59.5) | 6,940(60.0) | 3.96 | < 0.001 |
no | 14,455(41.1) | 2,905(43.2) | 3,005(42.0) | 3919(40.5) | 4,626(40.0) | |||
Missing | Yes | 1,005(2.8) | 304(4.3) | 323(4.3) | 206(2.1) | 172(1.5) | −12.15 | < 0.001 |
no | 35,131(97.2) | 6,725(95.7) | 7,163(95.7) | 9,677(97.9) | 11,566(98.5) | |||
Masking | ||||||||
None | Yes | 20,426(56.9) | 3,923(56.6) | 4,116(55.4) | 5,765(58.6) | 6,622(56.5) | 0.84 | 0.404 |
no | 15,490(43.1) | 3,003(43.4) | 3,318(44.6) | 4,071(41.4) | 5,098(43.5) | |||
Missing | Yes | 220(0.6) | 103(1.5) | 52(0.7) | 47(0.5) | 18(0.2) | −9.52 | < 0.001 |
no | 35,916(99.4) | 6,926(98.5) | 7,434(99.3) | 9,836(99.5) | 11,720(99.8) | |||
Allocation | ||||||||
Randomized | Yes | 23,643(66.0) | 4,618(66.8) | 4,976(66.9) | 6,387(64.9) | 7,662(65.7) | −1.93 | 0.054 |
no | 12,196 | 2,292(33.2) | 2,458(33.1) | 3,447(35.1) | 3,999(34.3) | |||
Missing | Yes | 297(0.8) | 119(1.7) | 52(0.7) | 49(0.5) | 77(0.7) | −6.02 | < 0.001 |
no | 35,839(99.2) | 6910(98.3) | 7434(99.3) | 9,834(99.5) | 11,661(99.3) | |||
Lead sponsor | ||||||||
Industry | Yes | 7,101(19.7) | 1,909(27.2) | 1,589(21.2) | 1,779(18.0) | 1,824(15.5) | −17.12 | < 0.001 |
no | 29,035(80.3) | 5,120(72.8) | 5,897(78.8) | 8,104(82.0) | 9,914(84.5) | |||
NIH | Yes | 469(1.3) | 166(2.4) | 102(1.4) | 95(1.0) | 106(0.9) | −7.29 | < 0.001 |
no | 35,667(98.7) | 6,863(97.6) | 7,384(98.6) | 9,788(99.0) | 11,632(99.1) | |||
US federal | Yes | 220(0.6) | 66(0.9) | 41(0.5) | 74(0.7) | 66(0.6) | −1.99 | 0.046 |
no | 35,916(99.4) | 6,963(99.1) | 7,445(99.5) | 9,809(99.3) | 11,672(99.4) | |||
Other | Yes | 28,346(78.4) | 4,888(69.5) | 5,754(76.9) | 7,962(80.6) | 9,742(83.0) | 19.02 | < 0.001 |
no | 7,790(21.6) | 2,141(30.5) | 1,732(23.1) | 1,921(19.4) | 1,996(17.0) |