Introduction
With the comprehensive implementation of the two-child policy on January
1, 2016, the birth rate of newborns in China has been significantly
increased in the recent years. According to the 2019 China Health
Statistics Yearbook [1], the number of pediatric
outpatient visits in the general hospitals of China has reached to 270
million in 2018, with an increase of 107% from over 2009, showing an
increasing trend year by year. The pediatric medical services are facing
great challenges due to this increase. According to the White Paper on
Drug Safety Investigation Report for Children in 2016, there were
176,652 domestic drug approvals by June 2016, wherein only 3,517 (2%)
were of children. The lack of
specific drugs and medication information for children in
drug labels have always been the
issues of concerns all over the world. Due to lack of information on
pediatric medications in the drug labels,
the off-label use of drugs is
widespread in children. Previous studies have reported that the
incidence of off-label medication use ranged from 28.3% to 46.5% in
pediatrics [2-5].
The off-label drug use is associated
with the occurrence of adverse drug events [6, 7],
posing a great hidden danger to medication therapy and patient
safety[8]. Therefore, clinical research on
pediatric drugs has been further strengthened in recent years.
Since 2011, a series of measures have been taken to encourage the
research, development and production of specific drugs and their
suitable dosage forms for pediatric patients in China[8]. In May 2014, the former State Health and
Family Planning Commission and other six ministries and commissions have
issued ”Several Opinions on Safeguarding Drug Use for Children” (No.29
[2014] of the State Health and Family Planning Commission), setting
forth specific requirements for safeguarding the drug use in children by
encouraging research and development, speeding up the application and
evaluation, and improving the system construction. The National Health
Committee and other departments have issued three batches of pediatric
drug lists for research and development by the end of 2019[9]. With the encouraging measures, the number of
clinical trial institutions qualified for conducting pediatric clinical
trials in China has been significantly increased in recent years[8]. Thus, in this study,
clinical trials of drugs with
indications in children were analyzed in China to provide reference for
research and development of pediatric drugs and formulation of relevant
policies.