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Table 1 Characteristics of interventional trials registered in ClinicalTrials.gov, 2008–2019

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)

  
  1. a Cochran-Armitage test for temporal trend of four time subsets