Pediatric clinical trials in mainland China over the past decade (from
2009 to 2020)
Abstract
Like most areas worldwide, there is a shortage of pediatric drugs in
mainland China to provide prescriptions. The Chinese government recently
launched policies and incentives to encourage pediatric drug development
and clinical trials. However, few data are available on the
characteristics or development trends of these trials. We extracted
source data from the Chinese Clinical Trials Registry and Information
Transparency Platform and systematically reviewed the pediatric clinical
trials conducted in mainland China from 2009–2020, providing data
support to policy makers and industry stakeholders. This study includes
487 pediatric clinical trials.Over the past decade, the number of
pediatric trials has increased annually, especially since 2016.The most
common therapeutic areas were infectious diseases (n=108, 22.2%),agents
for preventive purpose (n=99,20.3%), and neurological and psychiatric
diseases (n=71,14.6%). The number of clinical trials involving epilepsy
(39,10.1%), asthma (33,8.5%), and influenza (24,6.2%) were the
highest. The distribution of leading institutions is unbalanced in
mainland China, with most units in East China (34.0%) and few in
Southwest China (6.9%). China has made constant progress in improving
the R&D environment of pediatric drugs and increasing pediatric trials.
However, a wide gap in pediatric drug development remains between China
and developed countries. The pharmaceutical industry in China still
faces grim setbacks, including study duplication, a lack of innovation,
and poor research design. Thus, the Chinese government should adjust
their policies to improve innovation and clinical design capacity, and
to optimize resource allocation between regions.