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追踪跨医学专业的数字疗法研究:来自临床试验的证据.gov
Lars Masanneck1,2, Ariel D Stern2,3,4
1Department of Neurology, Medical Faculty University Hospital Düsseldorf, Düsseldorf, Germany.
Clinical pharmacology and therapeutics
|April 2, 2024
概括
自2005年以来,数字疗法 (DTx) 临床试验每年增长超过22%,特别是在心理健康领域. 参与者数量的增加表明对更强大,国际协调的DTx研究的需求.
科学领域:
- 数字疗法 (DTx) 是基于证据的软件干预的快速发展领域.
- DTx的研究跨越了各种医学专业,反映了数字解决方案在医疗保健中的整合.
背景情况:
- 医疗保健正在越来越多地转向以患者为中心的在线模式.
- 数字疗法 (DTx) 是针对医疗条件的基于软件的干预措施.
- 由于COVID-19大流行,加快了数字健康投资和远程医疗服务的提供.
研究的目的:
- 分析数字疗法 (DTx) 临床试验的增长,资金和研发特征.
- 检查DTx试验学科,参与者数量和2005年至2022年的地理分布的趋势.
主要方法:
- 来自ClinicalTrials.gov (2005-2022) 的5889个注册的DTx试验的分析.
- 使用ICD-11系统分类的试验,包括正在进行,招募或已完成的研究.
- 评估试验增长率,资金来源,医学专业和参与者数量.
主要成果:
- 自2011年以来,DTx试验增加了五倍以上,自2005年以来的复合年增长率为22.82%.
- 精神病学,神经学,瘤学和内分泌学是关键的增长驱动力,精神健康试验主导了最近的研究.
- 大多数试验仍然是单一中心的,但参与者的中位数有所增加;行业资金因学科而异.
结论:
- DTx试验显示出显著的增长,反映了远程医疗保健的趋势,并被数字健康投资放大.
- 越来越多的参与者表明对严格的DTx证据的需求越来越大.
- 加强国际合作和标准化评估对于在不同环境中有效和有效的DTx研究至关重要.
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