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 evaluate the quality of the registration information for trials sponsored by China registered in the WHO International Clinical Trial Registration Platform (ICTRP) primary registries or other registries that meet the requirements of the International Committee Medical Journal Editor (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry – India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scoreda median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.
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 metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.
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.