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.

Atomoxetine is the first non-stimulant medication approved by the US Food and Drug Administration for the treatment of attention deficit/hyperactivity disorder (ADHD). It can significantly improve ADHD symptoms, with good efficacy and tolerability. However, its efficacy was not consistent among all patients, especially for pediatric population. Due to marked heterogeneity in treatment response, a precision therapy should be developed and evaluated to guide treatment planning at the individual level. We have gained a better understanding of the pharmacokinetic profile. This review summarized some factors affecting peak concentrations of atomoxetine, including food, CYP2D6 and CYP2C19 phenotypes, and drug-drug interactions. The association between response and genetic polymorphisms of genes encoding the pharmacological targets such as norepinephrine transporter (NET/SLC6A2) and dopamine β hydroxylase (DBH) was also discussed. Based on the well-developed and validated assays for monitoring plasma concentrations of atomoxetine, the therapeutic reference range in pediatric patients with ADHD proposed by several studies was summarized. However, supporting evidence on the relationship between systemic atomoxetine exposure levels and clinical response is far from sufficient. We have to create evidence to characterize clearly the dose-exposure relationship, to establish clinically relevant metric for systemic exposure, to define a therapeutic exposure range, and to provide a dose-adaptation strategy before implementing personalized dosing for atomoxetine in children with ADHD. Personalizing atomoxetine dosage may be even more complex than we anticipated, but we can be optimistic about the future based on the remarkable advances in understanding the nature and causes of ADHD, as well as environmental stressors.