Abstract:Through analysis of clinical trials data of medical devices, the method of bibliometrics was adopted to evaluate the
industry vitality from registration quantities, conditions, sponsors, phases and other aspects. There were 33127 records of clinical
trial registrations of medical devices in the whole world, 1182 were in China; the United States and Europe were the main countries/
regions that carried out clinical trials of medical device. All the clinical trials covered a total of 3036 conditions all over the world
and 967 conditions in China, most of which were vascular diseases and heart diseases. There were more than 10000 sponsors all over
the world, in which there were 45 ones with more than 100 registrations. There were more than 400 sponsors in China, in which there
were 22 ones with over 10 registrations. The numbers of clinical trials in phase IV were the largest. The deep analysis of clinical trials
information of medical devices can help to grasp the research status and development trends, and also provide information support
based on data and facts for scientific decision-making, business investment, and think tank research in China.
张婷,陈娟,池慧,欧阳昭连. 医疗器械临床试验注册特点研究[J]. 中国医疗设备, 2018, 33(10): 113-118.
ZHANG Ting, CHEN Juan, CHI Hui, OUYANG Zhaolian. Study on the Characteristics of Clinical Trial Registration of Medical Devices. China Medical Devices, 2018, 33(10): 113-118.