RESULTS
A total of 347 clinical trials with indications including ”er” of infant
and child were retrieved in Chinese or ”adolescent” were screened for
inclusion. Of these, 77 trials were excluded due to duplications and
repeated registrations, and 11 trials have been suspended, 2 non-drug
trials, and one trial with indications not for children were excluded.
Finally, there were 256 trials included for data extraction and
analysis, accounting for 2.61% of the total registered number as of
January 9, 2020.
General characteristics of
the trials with indications for children in China
The general characteristics of trials with indications for children in
China were shown in table 1. Considering the 75 multiple-center trials,
the number of centers was 8(3~377), and the trial with
377 centers was an international multiple-center phase Ⅳ clinical
trial. In addition, 11 of the 16
trials for which a data safety monitoring committee have been
established were multiple-center clinical trials. Of the 256 trials, the
initial registration date of the trial was from July 2, 2013 to January
7, 2020, and the first ethical approval date of the trials was from
September 19, 2007 to December 26, 2019. By considering the first
ethical approval date, the number and the phase of trials distributed in
different years was shown in figure 1.