医疗器械临床试验注册特点研究

Study on the Characteristics of Clinical Trial Registration of Medical Devices

通过对医疗器械临床试验数据进行采集、分析,采用文献计量学的方法,从注册数量、适应症、申办机构、试验分期等角度来评价医疗器械领域行业活力。研究结果显示,全球医疗器械临床试验注册共有33127项,中国有1182项;美国和欧洲是主要开展医疗器械临床试验的国家/地区;全球和中国医疗器械临床试验分别涵盖适应证3036个、967个,其中数量最多的均是血管疾病和心脏病;全球医疗器械临床试验申办机构共有一万多个,临床试验登记数量超过100项的机构有45个;中国共有400多家临床申办机构,注册数量超过10项的机构有22个;全球和中国均是处于四期临床试验的数量最多。通过对医疗器械临床试验注册特点进行分析,全面把握医疗器械临床试验的研究现状和发展态势,为我国科学决策、企业投资、智库研究等提供基于数据和事实的信息支撑。

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 scientifc decision-making, business investment, and think tank research in China.