数字疗法产品监管过程中的焦点问题调研

Investigation and survey of focus issues in the supervised process of digital therapeutics products

目的:调研数字疗法(DTx)产品监管过程中的焦点问题,以推动医疗行业进入健康发展的良性轨道。方法:采用半结构化的深度访谈方法,通过德尔菲专家咨询法确定访谈大纲,利用滚雪球抽样方式确定访谈对象,对入选的21名受访对象根据确定好的访谈大纲依次进行访谈,并由两名研究人员对访谈过程进行文字记录并整理。采用Colaizzi七步分析法对访谈资料进行归纳提炼,针对访谈中反复出现的DTx产品监管中的共性焦点问题进行凝练和总结。结果:DTx产品监管中的焦点问题集中在DTx的监管分类尚不明确、DTx处理对象的客观性有待探讨、缺乏DTx效果评价的临床路径和临床试验指导原则以及DTx产品的质量评价指标的安全性和有效性4个方面应引起关注。结论:基于对DTx生产研发企业的深度调研,能够准确找出DTx产业健康快速发展过程和监管过程中的焦点问题,为DTx产品的标准化提供参考。

Objective:To investigate and survey the focus issue in the supervision process for digital therapeutics(DTx)products,so as to promote the medical industry into a healthy track of health development.Methods:Semi-structured depth interview method was adopted to conduct analysis on this study.The Delphi expert consultation method was adopted to determine the interview outline,and snowball sampling method was used to determine interview object.A total of selected 21 interviewees were interviewed in turn according to the confirmed interview outline.The whole interview process was recorded and sorted out by two researchers.The Colaizzi's seven-step analysis method was adopted to summarize and refine the interview data.The general focus issue that repeatedly occurred in the supervision of DTx product in interview were summarized and concluded.Results:In the supervision of DTx product,the focus issues concentrated at 4 aspects which included the classification of supervision was not clear,and the objectivity of processed object of DTx need be further discussed,and the clinical pathways and clinical trial guidelines principle of DTx effective evaluation were lack,and the safety and effectiveness of evaluation indicators of the quality of DTx product should cause concerns.Conclusion:Based on in-depth interviews for DTx production and R&D enterprises,it can accurately identify the focus issues in the process of healthy and rapid development of the DTx industry and the process of supervision,which will provide reference for the standardization of DTx products.