在丹麦进行分散的临床试验时面临的挑战
Ditte Weber1, Michelle Birknow2, Louise Hansen3
1Department of Sustainability and Planning, Aalborg University.
Studies in health technology and informatics
|May 13, 2025
概括
丹麦的分散临床试验 (DCT) 在定义活动,招聘,数据管理和参与者安全监督方面面临挑战. 解决这些问题需要合作和标准化方法才能成功实施.
科学领域:
- 临床研究方法论临床研究方法论
- 医疗信息学 医疗信息学
- 监管科学是一种监管科学.
背景情况:
- 分散临床试验 (DCT) 提供了潜在的好处,但也带来了独特的实施挑战.
- 利益相关者的观点对于理解和克服DCT采用障碍至关重要.
研究的目的:
- 从关键利益相关者的角度确定和分析在丹麦进行DCT的挑战.
- 为在丹麦医疗保健环境中优化DCT实施提供见解.
主要方法:
- 对DCT实施的利益相关者反的定性分析.
- 确定关键挑战领域,包括运营,技术和安全方面.
主要成果:
- 在定义和传播DCT活动和招聘策略时发现的挑战.
- 在远程数据访问,终端验证,IT系统集成和研究医疗产品 (IMP) 管理方面的困难.
- 对副作用报告的准确性和主要调查员 (PI) 对参与者安全 (TP) 的监督存在担忧.
结论:
- 在丹麦成功实施DCT需要解决运营执行,数据管理和安全监督方面的挑战.
- 建立国家工作组表明采取积极的方法来解决与DCT相关的问题.
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