Trials screening and data extraction
Trials with indications of ”er” in
pediatric patients in Chinese or ”adolescent”
were
retrieved for inclusion. Two authors have respectively screened the
retrieved trials, and excluded the
repeated registration trials, trials
that have been suspended, non-drug trials, and trials without
indications for children. Two authors have reviewed the full information
of all the included trials and extracted the study characteristics, and
any disagreements were resolved through discussion or by consulting a
third author. The following information of the trials, including
registration number, trial status,
trial phase, date of first ethical approval, name of the sponsor and
province of the sponsor located, the
first affiliation and province of
the principal investigator located, number of research centers, name,
type, dosage form and indications of the drug studied, age of the
subjects, children’s age specified in the indication, whether a data
monitoring committee (DMC) have been established, and whether insurance
had been purchased for participants, were recorded. We defined the first
ethical approval date of the trials as the date of the trials to make
annual trial number statistics. The provinces of the sponsor and the
principal investigator were divided into seven regions according to the
China’s seven geographical divisions, the north, east, south, central,
northeast, northwest and the southwest. For foreign sponsors, their
registered province was recorded in China. For drugs with indications
for adults and children, only the indications for only children were
recorded. In this study, the indications of studied drugs were coded
according to the International Statistic Classification of Diseases and
Related Health Problems, Tenth Revision, International Classification of
Diseases (ICD)-10 classification.