Table 1. Characteristics of 612 Pediatric Trials Published in Leading Pediatric and General Medical Journals From 2011 to 2020a.
Characteristic | Trials, No. (%) |
---|---|
Trial allocation | |
Randomized | 574 (93.8) |
Not randomized | 35 (5.7) |
Not specified | 3 (0.5) |
Trial masking | |
Nonblinded | 159 (26.0) |
Open-label | 153 (25.0) |
Double-blind | 127 (20.8) |
Single-blind | 98 (16.0) |
Other | 27 (4.4) |
Not specified | 48 (7.8) |
Trial phase | |
1 | 17 (2.8) |
2 | 46 (7.5) |
3 | 73 (11.9) |
4 | 14 (2.3) |
Not specified | 59 (9.6) |
Not applicable | 403 (65.8) |
Participant enrollment | |
<100 | 172 (28.1) |
100-499 | 284 (46.4) |
>500 | 156 (25.5) |
Trial intervention | |
Behavioral | 244 (39.9) |
Drug or biologic agent | 195 (31.9) |
Device or procedure | 75 (12.3) |
Dietary supplement | 44 (7.2) |
Health services | 21 (3.4) |
Screening or referral | 26 (4.2) |
Other | 7 (1.1) |
Disease studiedb | |
Infectious diseases | 95 (14.8) |
Endocrine or metabolic diseases | 63 (9.8) |
Lung diseases | 61 (9.5) |
Neurologic disorders | 56 (8.7) |
Developmental disorders | 53 (8.2) |
Nutrition, obesity, and growth | 52 (8.1) |
Neonatal disorders | 49 (7.6) |
Cancer | 31 (4.8) |
Gastrointestinal disorders | 29 (4.5) |
Mental illness | 26 (4.0) |
Substance use disorders | 25 (3.9) |
Social determinants of health | 22 (3.4) |
Sexual activity or pregnancy | 18 (2.8) |
Cardiovascular disease | 16 (2.5) |
Injuries or physical trauma | 9 (1.4) |
Other | 38 (5.9) |
Funding source | |
Public | 345 (55.9) |
Private | 114 (18.5) |
Public and private | 128 (20.7) |
None reported | 30 (4.9) |
Recruitment sites | |
1 | 367 (64.3) |
2-4 | 79 (13.8) |
>5 | 125 (21.9) |
Participant primary language reported in article | 162 (26.4) |
Article reported community stakeholder involvement | 59 (9.6) |
Published in journal with race or ethnicity reporting statement | 425 (69.4) |
Socioeconomic data reported in articlec | 296 (48.3) |
JAMA Pediatrics, The Lancet Child & Adolescent Health, Pediatrics, Journal of Adolescent Health, The Journal of Pediatrics, New England Journal of Medicine, The Lancet, JAMA, BMJ, and PLoS Medicine.
In 31 trials, more than 1 disease category was studied.
Included insurance type or status, household income, community-level income, caregiver education, caregiver employment status, and receipt of social benefits.