从两个多中心随机对照试验中得出的经验教训,这些试验是在社区环境中的药房中进行的:回顾性项目管理分析
Christopher J Byrne1,2, Sarah K Inglis3, Andrew Radley4
1Division of Respiratory Medicine and Gastroenterology, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland. c.x.byrne@dundee.ac.uk.
Trials
|November 1, 2025
概括
在社区药房进行随机对照试验 (RCT) 提出了独特的项目管理挑战. 关键的教训强调早期规划,简化流程和专注的试验管理,以获得成功的药房研究.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 药房实践 在药房实践.
- 临床试验管理 临床试验管理
背景情况:
- 社区药房是非常容易进入的医疗保健机构.
- 在社区药房内进行随机对照试验 (RCT) 的兴趣越来越大.
- 关于在药房进行RCT的项目管理方面的证据有限.
研究的目的:
- 在两个高收入国家的社区药房中进行两次RCT的经验教训.
- 确定在社区药房设置中管理RCT的挑战和机会.
主要方法:
- 追溯审查行政和试验活动记录.
- 面对面和在线会议以确定所学到的经验教训.
- 使用项目管理研究所的生命周期模型绘制利益相关者映射和框架调查结果.
- 用于结果估计的描述性统计.
主要成果:
- 招募了96家药房,在所有项目阶段 (启动,规划,执行/监控,关闭) 确定了任务.
- 药房招聘,试验药物供应文件,参与者招聘和合同谈判都是时间密集的.
- 确定了八个关键的利益相关者群体,并吸取了三十个经验教训,特别是关于利益相关者参与,选址,流程简化,数据优化和成本考虑.
结论:
- 在社区药房中进行RCT涉及整个试验生命周期的独特项目管理挑战.
- 关键的教训包括早期规划的必要性,简化流程以尽量减少员工负担,并适应药房特定的约束.
- 有效的管理需要专注的,资源丰富的员工,以参与利益相关者和量身定制的支持.
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