• 1. Peking University First Hospital, Beijing 100191, P.R.China;
  • 2. Institute for Clinical Research, Peking University, Beijing 100191, P.R.China;
WU Yangfeng, Email: wuyf@bjmu.edu.cn
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Objective To compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.Methods We randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed them up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.Results Among all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% completed and 69.5% disclosed results publicly before the end of follow up, and differences between countries were statistically significant (P<0.05). Two thirds of the trials in China were phase III/IV trials; in contrast, most of the clinical trials in the United States and Europe were phase I/II trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.Conclusions The number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmatheutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.