Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

Table 1 General characteristics of 588 pediatric clinical trials in China

Items	Frequency (%)
Trial status
Ongoing	372 (63.27%)
Completed	216 (36.73%)
Trial phase
Phase I	103 (17.52%)
Phase II	79 (13.44%)
Phase III	273 (46.43%)
Phase IV	91 (15.48%)
Others	42 (7.14%)
Subjects^a
Prematurity	1 (0.17%)
Neonates	2 (0.34%)
Infants	94 (15.99%)
Toddlers and school children	113 (19.22%)
Adolescents	102 (17.35%)
Children and adults	276 (46.94%)
Trial range
China	521 (88.61%)
International	67 (11.39%)
No. of centers
Single-centre trial	107 (18.20%)
Multiple-centre trial	481 (81.80%)
Target subject number ^b
Phase I	100 (8, 588)
Phase II	240 (20, 1980)
Phase III	701.5 (28, 20,000)
Phase IV	600 (10, 600,000)
Others	395 (12, 16,000)
DMC had been establish	76 (12.93%)
Insurance had been purchased	241 (40.99%)

^aChildren were divided to prematurity, neonates (< 28 days old), infants (< 3 years old), toddlers and school children (< 13 years old), and adolescents (13 ~ 18 years old)
^bMedian (range) was used for target subject number

ISSN: 1471-2431