Department of Health Policy and Technology Assessment, National Institute of Public Health, Minami 2-3-6, Wako, Saitama 351-0197, Japan.
Department of Health Policy and Technology Assessment, National Institute of Public Health, Minami 2-3-6, Wako, Saitama 351-0197, Japan; Faculty of Global Nursing, Iryo Sosei University, Koaota 1-3-4, Kashiwa, Chiba 277-0803, Japan.
Chin Clin Oncol. 2021 Jun;10(3):28. doi: 10.21037/cco-21-17.
The characteristics and comparison of countries regarding clinical trials for cancer were unknown. The World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP) are providing data from various countries and releases them generally in a downloadable format. We aimed to examine and descriptively identify the number of cancer clinical trials registered in the world and the fundamental characteristics in Asian 4 countries of China, India, Japan and South Korea, focusing on study characteristics, e.g., phase or targeted size, using the WHO-ICTRP.
We extracted information on cancer clinical studies in the ICTRP database on September 20, 2019. Then, we performed a cross-sectional study on the annual number of registered studies and country, registered registry, phase, target sizes and sponsors.
We identified 80,677 cancer clinical studies. The annual number of registered cancer clinical studies significantly increased between 2005 and 2018 (3,172 to 8,156, β =382.2, 95% CI: 329.6, 434.8). Among the Asian 4 countries, the numbers of trials were significantly increasing in 2005-2018 (P<0.001). The characteristics on interventional studies for cancer differed in those 4 countries, e.g., the registered registries, phase and sponsors, compared with the US.
This study descriptively clarified an increase and the characteristics of cancer clinical trials in Asian 4 countries. It suggests to take that characteristics into account and select a database or data source discreetly for analysis of clinical trials, according to the purpose of the research and the required data.
各国癌症临床试验的特点和比较尚不清楚。世界卫生组织-国际临床试验注册平台（WHO-ICTRP）正在提供来自各国的数据，并以可下载的格式发布。我们旨在检查和描述性地确定世界范围内癌症临床试验的数量以及中国、印度、日本和韩国这四个亚洲国家的基本特征，重点是研究特征，例如阶段或目标规模，使用 WHO-ICTRP。
我们于 2019 年 9 月 20 日从 ICTRP 数据库中提取癌症临床研究信息。然后，我们对每年注册研究的数量和国家、注册机构、阶段、目标规模和赞助商进行了横断面研究。
我们确定了 80677 项癌症临床研究。2005 年至 2018 年，注册癌症临床研究的数量呈显著增加趋势（3172 至 8156，β=382.2，95%CI：329.6，434.8）。在亚洲 4 个国家中，2005-2018 年试验数量呈显著增加趋势（P<0.001）。与美国相比，这 4 个国家的癌症干预性研究特征存在差异，例如注册机构、阶段和赞助商。
本研究描述性地阐明了亚洲 4 个国家癌症临床试验的增加和特点。这表明，根据研究目的和所需数据，在分析临床试验时，应谨慎考虑这些特征，并选择数据库或数据源。
