Abstract:

Objective To observe the global and Chinese children clinical trial registration. Methods By Using advanced search of ClinicalTrials.gov database, some search rules were limited and the number of children aged from 0 to 17 clinical trial registration was collected. We ascertained the countries to obtain the number of children clinical trial registration. According to the different groups as sub-population, recruitment and study type, registration number was further stratified for analysis.Results There were 43 349 studies had been registered in the ClinicalTrials.gov until December 31, 2015, America, Europe, Asia, Australia, Africa accounts for 53.8%, 21.27%, 14.5%, 2.30%, 4.2% from total, respectively. The top 5 countries in registration numbers were United States, Canada, China, France and United Kingdom, Mainland China ranked 9th in countries list. It was found that registration number was highly correlated with the GDP (dollars) of country (correlation = 0.92), this indicator in children series was equal to 0.62. The ratio of the number of Preparing, Recruiting, Activated and Completion projects in United States was 1∶12∶5.5∶26.5, however, this ratio was 1∶8.6∶1.6∶8.0 in China. The number of observational study was one third of interventional's. Top 5 provinces in Mainland China were Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang, they accounted for 95.4%（1 151/1 207） of children clinical trial registration in Mainland China.Conclusion From the point of registration number, there is still a huge gap among China and Euro-American developed countries. Moreover, regional difference in China is very serious. Although change of concept for clinical trial registration from establishment to automatic registration is a slow and gradual process, but it can improve the quality of children clinical trial for China.