通过数字技术,分散的设计和以人为中心的终点增加喘临床试验:机遇和挑战
Job F M van Boven1, Richard W Costello2, Kit C B Roes3
1Department of Clinical Pharmacy & Pharmacology, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
The Lancet. Respiratory medicine
|December 8, 2024
概括
数字技术使得用于喘研究的远程数据收集成为可能,为分散的临床试验铺平了道路. 这种方法可以加快新喘治疗方法的开发和市场准入.
科学领域:
- 数字健康数字健康
- 临床试验设计 临床试验设计
- 呼吸系统医学 呼吸系统医学
背景情况:
- 像智能吸入器和可穿戴设备这样的数字技术为复杂的呼吸道疾病 (如喘) 提供了远程,客观的数据收集.
- 这些工具促进了向去中心化临床试验 (DCT) 的转变,使研究超出传统环境.
- DCT利用远程数据收集和监控来评估干预措施.
研究的目的:
- 讨论临床试验中数字技术和终点的应用.
- 探索混合和分散的试验设计,包括一个完全分散的喘试验.
- 从各种利益相关者的角度分析实施这些试验的优点,弱点,机会和威胁.
主要方法:
- 审查和讨论临床研究中的数字技术应用.
- 混合和分散的试验模型的概念化和描述.
- 探索利益相关者的观点 (临床医生,患者,低资源环境,监管机构).
主要成果:
- 数字技术使得用于喘研究的客观,细粒度和非侵入性数据收集成为可能.
- 分散试验可以提高人口的包容性,个性化,可持续性,并降低成本.
- 实施为加速新喘治疗药物进入市场提供了机会.
结论:
- 数字技术正在通过实现分散的临床试验来改变喘研究.
- 在评估干预措施,改善患者获取和加快治疗开发方面,DCT提供了显著的优势.
- 仔细考虑优势,弱点,机遇和威胁对于在不同环境中成功实施至关重要.
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