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.
Objective To investigate the number of Chinese clinical trials and the completeness of registered information on the source of their funding. Methods We searched the five primary registers in the World Health Organization’s International Clinical Trial Registration Platform to identify Chinese clinical trials, calculated the number Chinese clinical trials with specific funding and evaluated the completeness of the information on the source of this funding. Results We identified 383 registered Chinese clinical trials, of which 219 (27 trials per year on average) were registered in clinicaltrials.gov, 94 in the Chinese Clinical Trial Register Center (113 per year on average), 62 in controlled-trials.com (12.4 per year on average) and 8 (1.6 per year on average) in the Australian and New Zealand Clinical Trials Registry. 360 trials had some information on their source of funding: 230 from the mainland of China (62 funded by colleges/universities, 47 by national/local organizations, 47 by the Ministry of Science and Technology, 34 by hospitals, 28 by commercial organizations, 9 by international foundations, and 3 by the Ministry of Health), 117 from Hongkong and 13 from Taiwan. The information in the registers on the source of funding was incomplete. Conclusion The number of funded Chinese clinical trials in these registers is too small. The registrations should be improved to improve the completeness of information on the source of funding. It is important to disseminate the importance of registering clinical trials and doing so in a local register to promote the transparency and accessibility of trial registration.
ObjectivesTo analyze the development of acupuncture registered trials based on WHO international clinical trial registration platform (ICTRP) in the past 5 years.MethodsWHO ICTRP database was electronically searched to collect acupuncture-related clinical trials registered from January 1st, 2014 to December 31st, 2018. Two reviewers independently screened items, extracted data, and descriptive analysis was performed for the included trials.ResultsThe results showed that there were 1 556 registered clinical trials on acupuncture, and the most registered year was 2017. China was in the main country in applying for acupuncture-related clinical trials, however, the most registered unit was Kyung Hee University in Korea. The trials were mainly interventional research, mostly used randomized, blinded methods, and design modes were mainly based on parallel trials. In clinical trial phase, the majority were in the clinical trial period of treatment of new technologies. The field of clinical research was expected to be on pain in the future.ConclusionsAlthough acupuncture research is currently in a good stage of development, it should still value on the quality and innovative training of relevant trials, strengthen Chinese ties with other countries, focus on regional, domestic and international cooperation, expand research types, and enhance acupuncture applicability.
ObjectivesTo analyze the research status and hot spots of hypertension-related clinical trials in special Chinese population registered on the Chinese Clinical Trial Registry (ChiCTR), so as to provide a basis for the development of hypertension-related research in special population in China.MethodsThe ChiCTR was searched online (up to August 31st, 2019, no limitation in the status of trial registration), all clinical trials on hypertension in special population were collected, and the general characteristics, researched diseases, research types, intervention measures and main outcomes of the trials were analyzed.ResultsA total of 64 hypertension-related clinical trials in special population registered in the ChiCTR were included, including 41 (64.1%) trials registered in last 3 years. The registration status of 46 (71.9%) trials was pre-registration. The registered authors were mainly from colleges and universities or medical institutions (n = 61, 95.3%), of which 60.9% were registered in Beijing, Shanghai, Guangdong, Zhejiang, Jiangsu and Hebei. The researched diseases mainly included elderly hypertension and hypertensive stroke, accounting for 50% of the total. Additionally, 37 (57.8%) clinical trials were intervention studies, of which 21 (56.7%) were drug-based intervention studies. Blood pressure, blood glucose, cardiovascular and cerebrovascular events, blood lipid, cranial MRI and Glasgow Coma Scale were the commonly used outcomes, accounting for 58.5% of the total outcomes. Most blood pressure measurements did not indicate the measurement method (n = 22, 64.7%).ConclusionsThe quantity of hypertension-related clinical trials in special population registered on the ChiCTR is increasing, however, there exists regional imbalance. The drug intervention-related clinical trials of elderly hypertension have become a research hot spot. However, blood pressure measurement method is not indicated in most trials, and some researchers do not register in time. Therefore, it is suggested that researchers should further strengthen the awareness of carrying out high-quality clinical trials.
Objective To analyze the current research status, characteristics and development trend of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyzed in terms of the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The studies conducted covered a total of 47 countries/regions, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total, and included 13 overseas regions. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and there were 213 large-sample studies with a sample size of more than 1 000 cases. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral herbal soup/granule interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule interventional studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.