招募和同意分散的临床试验参与者 - - 从试验@家庭RADIAL概念验证试验中获得的经验
Bart Lagerwaard1, Linda Rutgrink2, Danny van Weelij3
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Clinical pharmacology and therapeutics
|September 4, 2025
概括
分散临床试验 (DCT) 面临招聘障碍. 研究数据库是有效的招聘,但eConsent过程有显著的下降,强调需要更简单的远程同意方法.
科学领域:
- 临床试验活动
- 数字健康技术
- 患者招募策略
背景情况:
- 由于物流负担,临床试验面临参与者招募的挑战.
- 分散临床试验 (DCT) 旨在通过将试验活动更接近参与者来减轻这些障碍.
- 越来越多地使用在线方法在DCT招聘和同意.
研究的目的:
- 在分散的临床试验环境中探索招聘策略.
- 评估远程电子知情同意的实施情况.
- 确定DCT参与者注册和远程同意的障碍和促进因素.
主要方法:
- 在RADIAL试验中,针对2型糖尿病的第四阶段研究采用了六个欧洲国家的分散方法.
- 招聘包括在线活动 (广告,社交媒体) 和研究数据库推广.
- 远程同意包括电子同意,远程医疗,电子识别和电子签名.
主要成果:
- 在线招聘的预先选完成率和入学率较低.
- 研究数据库的推广非常有效,在8个分散组中贡献了7个.
- 在同意阶段发生了显著的69%的预先查; 11/15名参与者成功完成了eConsent.
结论:
- 定制的招聘策略和简化远程同意流程对于DCT的效率和可访问性至关重要.
- 在线招聘需要优化目标和关键词策略.
- 由于监管的不同,远程eConsent系统的实施可能是资源密集和复杂的.
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