基于ClinicalTrials.gov的医学人工智能临床试验注册现状分析

目的:分析医学人工智能临床试验注册现状,为医学人工智能临床转化研究提供参考和证据支持。方法:通过ClinicalTrials.gov注册平台对医学人工智能临床试验数据进行采集、分析,采用文献计量学及对比研究的方法,从注册数量、研究类型、分期、适应证和申办者等角度进行医学人工智能临床试验注册现状研究。结果与结论:全球医学人工智能临床试验共649项,中国50项,位列全球第二位,但与美国尚存在较大差距;全球医学人工智能随机对照试验295项,中国12项;国际多中心临床试验32项,中国大陆未见参与;全球医学人工智能临床试验处于Ⅱ期的数量最多;全球医学人工智能临床试验适应证主要集中于疾病监测或健康管理、医学影像辅助诊断、疾病预测和治疗等,中国主要集中于诸如眼病筛查、肿瘤诊断等医学影像辅助诊断;全球医学人工智能临床试验的申办者共422个,中国29个,注册数量前15位申办者中大多为研究机构和医疗机构。

An Analysis of the Status of Clinical Trial Registration in Medical Artificial Intelligence Based on ClinicalTrials.gov

Objective:To analyze the status of clinical trials registration in medical artificial intelligence and provide reference and evidence support for medical artificial intelligence clinical transformation research.Methods:By collecting and analyzing the clinical trial data of medical artificial intelligence through the ClinicalTrials.gov registration platform,the methods of bibliometrics and contrast were adopted to analyze the status of clinical trials registration in medical artificial intelligence from registration quantities,type,phases,indications,sponsors and other aspects.Results and conclusion:There were 649 records of clinical trial registrations of medical artificial intelligence in the whole world.50 were in China,which was ranking second in the world,but there was still a big gap with the United States.There were 295 randomized controlled trials of medical artificial intelligence all over the world,12 were in China;and there were 32 multi-regional clinical trials of medical artificial intelligence,no participation in China's Mainland.The numbers of clinical trials in phase 2 were the largest.The global medical artificial intelligence clinical trial indications mainly focused on disease surveillance or health management,medical image-assisted diagnosis,disease prediction and treatment,etc.China mainly focused on medical image-assisted diagnosis such as eye disease screening and tumor diagnosis.There were 422 sponsors all over the world,29 were in China.The top 15 sponsors were mainly research institutions and medical institutions.