<div>A total of 67 trials (including 4
phase Ⅰ, 20 phase Ⅱ, 26 phase Ⅲ, and 11 phase Ⅳ trials) were conducted
among children age ranging from 0 to 18 years. Ten trials included both
adults and children as subjects, and 179 trials (including all 160
bioequivalence trials) included only adults as subjects. A simple
regression model revealed that the overall average annual growth rate of
the number of trials was 43.30% (P=0.0000). As shown in figure 1, the
number of trials included had been significantly increased since 2017.
In addition, a simple regression model based on the number of phases I
to IV trials showed an average annual growth rate of 22.12% (P=0.001).</div><div><b>Geographical location</b><b>of the trials with
indications for children in China</b></div><div>The geographical distribution of the sponsors of the 256 trials was
shown in figure 2. More than 40% of the sponsors were located in the
eastern China. The geographical distribution of the principal
investigator involved in the 256 trials was shown in figure 3, and the
trial institutions were mainly distributed in the east, the north and
the central China, with Beijing, Jiangsu and Shanghai as the major ones.</div><div><b>Distribution of the studied
drugs and its dosage form </b></div><div>The types of research drugs involved in the 256 trials and the
distribution of the main dosage forms were shown in figure 4. The drug
types mainly included were the chemical drugs, accounting for 76.17%.
Based on the age of indications, there were 102 drugs used for children
under 18 years age, i.e. children-specific drugs (39.84%), in which 3
drugs were used for premature infants and newborns, namely caffeine
citrate, porcine lung surfactant and hepatitis B vaccine, and 11 drugs
were used for only infants. The remaining 154 (60.16%) drugs were
indicated for both adults and children. Considering the dosage forms of
the 195 chemical drugs, tablets were the main ones, followed by
capsules, injections and granules. The other dosage forms were shown in
fig. 4 included syrup, powder, oral solution membrane and needle-free
percutaneous injection administration system, respectively. All
traditional Chinese medicine/natural drugs were special drugs for
children, and their dosage forms mainly included granules and patches.
Of the 40 kinds (15.63%) of biological products, 33 were specific drugs
for children, mainly in the form of injections.</div>