摘要
目的:研究已获美国食品药品监督管理局(FDA)批准的数字疗法(DTx)产品的临床试验开展情况,探索其临床试验设计原则。方法:选取6款已获美国FDA批准的DTx产品作为样本,产品应用领域覆盖精神障碍类、糖尿病、酒精或药物滥用以及慢性疼痛和弱视;通过ClinicalTrials.gov注册平台对产品临床试验数据进行采集,并利用Excel 2019软件对其研究设计、临床评价、受试对象等相关的9项指标进行统计分析。结果:6款DTx产品全部开展随机对照试验,研究类型均为干预性研究。平行分配是最主要的分配方法(占47.8%);盲法设计中非盲13项(占56.5%),单盲5项(占21.7%);研究目的中治疗性研究20项(占87.0%);上市时间较长、研究相对成熟的两款DTx产品,BlueStar和reSET-O,以支持性护理和卫生服务研究为目的开展了试验;关注产品可用性的临床试验14项(占60.9%),将可用性指标列入主要评价指标的临床试验8项(占34.8%),并可在临床试验阶段拓展研究DTx产品的适用年龄和适应证。结论:随机对照试验是DTx产品临床试验设计的“金标准”,研究人员应充分意识到可用性对DTx产品的重要性,并在临床试验设计中予以充分考虑。
Objective:To study the status of carrying out clinical experiment for the digital therapeutics(DTx)that was approved by Food and Drug Administration(FDA),so as to explore the design philosophy of that in clinical experiment.Methods:Six kinds of DTx products,which covered five major application fields included mental disorders,diabetes,alcohol or drug abuse,chronic pain and amblyopia,that were approved by the FDA of United State(US)were selected as representatives.The clinical trial data of the products were collected through the ClinicalTrials.gov registration platform,and 9 indicators related to study design,clinical evaluation and participants were statistically analyzed by using Excel 2019.Results:Randomized controlled trials were carried out in all 6 DTx products,and the study types of them were all interventional studies.Parallel assignment was the most of main distribution method(47.8%),and 13 items were non-blind(56.5%)and 5 items were single blind(21.7%)in the designs of blind methods.20 items(87.0%)were therapeutic researches in the purpose of researches.Two DTx products(BlueStar and reset-0),which researches were relative mature and times of market were relative longer,were performed experiment which aims were supporting nursing and health service.In addition,14 clinical experiments(60.9%)payed attention to the availability,and 8 clinical experiments(34.8%)included availability into main evaluation indicators.The applicable age range and indications of DTx products could be expanded to study in the clinical trial stage.Conclusion:Randomized controlled trial is the"gold standard"of clinical trial design of DTx products.Researchers should be fully aware of the importance of availability on DTx products and take sufficiently into account it in clinical trial design.
作者
徐宜蕙
张一帆
李杨
刘毅
刘亚芝
牛道恒
XU Yi-hui;ZHANG Yi-fan;LI Yang(China National Medical Device Co.,Ltd.,Beijing 100028,China;不详)
出处
《中国医学装备》
2022年第11期1-7,共7页
China Medical Equipment
基金
国家重点研发计划(2020YFC2007104)“多应用场景主动健康产品质量评价平台及体系研究”
中国药品监督管理研究会2022年度课题(2022-Y-Q-009)“数字疗法产品风险与监管需求研究”。