临床试验中的个性化和纵向电子知情同意:如何移动针头?
Evelien De Sutter1,2, Liese Barbier1,2, Pascal Borry3
1Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Digital health
|January 25, 2024
概括
电子知情同意 (eIC) 可以提高临床试验参与和效率. 然而,广泛采用面临挑战,需要标准化平台才能成功实施.
科学领域:
- 临床试验 临床试验
- 数字健康技术 数字健康技术
- 在知情同意的过程中,提供知情同意.
背景情况:
- 数字技术的进步正在改变临床试验环境.
- 电子知情同意 (eIC) 为参与者与研究人员的互动,试验参与和运营效率提供了潜在的改进.
- 个性化的eIC平台可以通过与研究团队的持续互动来加强参与者的参与.
研究的目的:
- 提供有关在临床试验中实施电子知情同意的机会和挑战的见解.
- 为促进eIC的广泛采用提供建议.
主要方法:
- 这一观点综合了临床试验中电子知情同意的当前知识.
- 它分析了潜在的好处和现有的实施障碍.
- 根据已识别的机遇和挑战,制定了关键建议.
主要成果:
- 电子知情同意为提高参与者的参与度和简化临床试验流程提供了重大机会.
- 持续存在的挑战阻碍了eIC的成功和广泛实施.
- 开发统一,标准化的eIC平台至关重要.
结论:
- 电子知情同意有可能彻底改变临床试验中的知情同意过程.
- 通过标准化和政策解决实施挑战对于实现eIC的全部好处至关重要.
- 建议在区域和国家层面进一步开发和采用统一的eIC平台.
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