临床试验的积累质量改善计划
Ellen Richmond1, Goli Samimi1, Margaret House1
1Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
Clinical trials (London, England)
|April 9, 2024
概括
积累质量改进计划通过不断监测数据以确定影响招聘的因素,提高了癌症预防试验的入学率. 这种实时分析允许进行响应性调整,以优化当前和未来研究的入学率.
科学领域:
- 临床试验 临床试验
- 预防癌症 预防癌症
- 医疗保健服务研究 医疗服务研究
背景情况:
- 早期癌症预防试验面临招募挑战,因为参与者缺乏立即的个人利益.
- 美国国家癌症研究所的癌症预防部门为应对这些挑战,制定了计入质量改进计划.
- 该计划旨在了解和优化在临床试验中累计活动的决定因素.
研究的目的:
- 描述积累质量改进计划 (AQIP) 以及其在提高早期癌症预防试验积累方面的作用.
- 突出AQIP实时数据收集,分析和可视化能力,以提高入学率.
主要方法:
- AQIP利用基于网络的基础设施在参与者,地点和研究层面收集,分析和存储定性和定量数据.
- 它捕获了详细的招聘数据,包括资格不合格或未同意的原因,以及特定地点的问题.
- 该程序包含招聘期刊,并可视化计时率与预测,提供绩效评级和改进建议.
主要成果:
- 从2014年到2022年,AQIP在39个联盟试验中实施,收集了全面的试验信息.
- 捕获的数据包括参与者级别的指标 (例如,查看图表,联系尝试,同意状态) 和站点/研究级别的因素 (例如,人员配置,协议修正).
- AQIP提供实时追踪累积率,绩效评估和干预建议.
结论:
- 持续的数据收集和质量改进对于克服早期癌症预防试验的招聘障碍至关重要.
- 在正在进行的试验中,AQIP可实现响应式策略修改和协议调整,以改善招募.
- 来自AQIP的数据将为未来的试验设计提供信息,以提高积累效率.
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