分散临床试验 (DCT) 的伦理挑战和考虑:从范围审查中的见解
Lijia Han1, Kai Hong Ooi1,2, Krisna Veni Balakrishnan3
1Medical Humanities and Ethics Unit, Faculty of Medicine, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Therapeutic innovation & regulatory science
|March 10, 2026
概括
分散临床试验 (DCT) 存在道德上的挑战. 该审查确定了同意和隐私等关键问题,并建议明确的指导方针和强有力的监督,以确保道德和有效的DCT实施.
科学领域:
- 临床研究 临床研究
- 数字健康数字健康
- 生物伦理学生物伦理学
背景情况:
- 分散临床试验 (DCT) 利用数字健康技术在传统场所之外进行研究.
- DCT提供了诸如增加参与者多样性和可访问性等好处,但也带来了重大的伦理挑战.
- 现有的监管框架不足以满足DCT的治理和监督需求.
研究的目的:
- 系统地识别和综合有关DCT的文献中报道的伦理挑战.
- 概述未来DCT道德监督指导和实践的建议.
主要方法:
- 根据Arksey和O'Malley的框架进行范围审查.
- 在PubMed,Web of Science和SCOPUS进行的同行评审文章的搜索.
- 对757份初始文件进行了严格的两阶段选过程,选择了32份用于分析.
主要成果:
- 确定了六个主要的道德挑战领域:电子知情同意,公平和访问,隐私和机密性,参与者的安全和福利,科学有效性和道德/监管监督.
- 对32篇精选文章的分析综合了DCT中报告的伦理问题.
结论:
- 清晰的指导方针,增强的数字素养,强大的数据保护和全面的监管框架对于解决DCT道德挑战至关重要.
- 可行的建议包括简化同意流程和改进技术支持.
- 需要进一步的研究,以确保DCT的伦理和有效行为.
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