Objective To know the current status of multinational clinical trials (MNCTs) in East Asia, and to find the characters of MNCTs in countries/regions.
Methods We downloaded the trial records of East Asia on May 8, 2008 from ClinicalTrials.gov and analyzed the data.
Results The number of clinical trials sponsored by industry was 125 in China Mainland, 196 in Taiwan, 134 in Hong Kong, 264 in Korea, and 231 in Japan, respectively. Of the total 654 clinical trials in East Asia, 307 (47%) trials were MNCTs, most of which were conducted by Euro-American pharmaceutical companies, such as Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis and Bristol-Myers Squibb. Main therapeutic areas were cancer, followed by CNS diseases, cardiovascular diseases, infectious diseases, diabetes mellitus and respiratory diseases. Trials in phaseⅢwere 198 (65%), in phaseⅣ32 (10%), others in phaseⅡorⅠ. One hundred and ninety trials (62%) were double-blind clinical trials, about half of them using placebo. The characters of clinical trials in China were: ① Most of MNCTs were large scale trials with big sample size and many study sites; ② Most of local trials were phase Ⅲ trials; ③ There were no phase Ⅰ trials. The characters in Taiwan, Hong Kong and Korea were: 1) Most of the trials (84% in Taiwan and 93% in Hong Kong, 72% in Korea) were MNCTs, 2) A lot of large scale trials were conducted with each other. The characters of clinical trials in Japan were: ① MNCTs were only 17%, ② Large scale trials were fewer.
Conclusion In East Asia, MNCTs are developing because of the initiation of the Europe and America pharmaceutical giants. It seems that the regulation in each country influence the development pattern of East Asia.
Citation： YAO Chen,Keiichi Sugino,GONG Qian,Yasuo Ohashi. Current Status of Multinational Clinical Trials in East Asia——Results of the Survey Using ClinicalTrials.gov. Chinese Journal of Evidence-Based Medicine, 2010, 10(2): 122-128. doi: 10.7507/1672-2531.20100302 Copy