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开发和评估多站点临床研究的客观试验性能指标:来自AlcHep网络的经验

Srinivasan Dasarathy¹, Wanzhu Tu², Annette Bellar¹

¹Department of Gastroenterology & Hepatology and Inflammation and Immunity, Cleveland Clinic, Cleveland, OH, United States of America.

Contemporary clinical trials

|January 12, 2024

概括

开发临床试验的客观绩效指标,如收益率和招聘指数,有助于评估研究质量并确定试验招聘和保留方面的改进领域.

科学领域:

临床研究方法论临床研究方法论
医疗信息学医学信息学
生物统计学生物统计学

背景情况:

招聘和保留对于临床研究的成功至关重要,但客观的绩效指标有限.
这项研究旨在开发和评估临床试验的客观绩效指标.
数据来源于酒精性肝炎网络的观察队列 (OBS) 和随机临床试验 (RCT) 臂.

研究的目的:

为评估临床试验绩效建立客观指标.
为了能够客观地评估研究质量.
识别影响试验绩效的因素.

主要方法:

开发了四个关键绩效指标:收益率 (YR),招聘指数 (RI),完成指数 (CI) 和协议遵守指数 (AI).
计算了这些指标,使用OBS和RCT手臂的8个地点的2250名查患者的数据.
分析了导致性能变化的因素.

主要成果:

在OBS (59%) 和RCT (57%) 两支手臂之间,招聘率相似.
与RCT (13.6%) 相比,OBS (63.6%) 的入学收益率明显高.
完成率为OBS的34.1%和RCT的46.3%. 性能指标在不同地点和研究部门之间有很大差异,受参与者,设计,团队和赞助商因素的影响.

结论:

客观的绩效指标为评估临床试验质量提供了可量化的基础.
这些指标有助于制定有针对性的策略,以提高研究绩效.
使用这些客观措施,可以制定特定地点的改进计划.

关键词:

与酒精有关的肝炎.临床试验临床试验是指临床试验的临床试验.对患者进行查.招聘方式招聘方式留住研究对象的保留

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