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.