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.