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一个开源的R套件用于检测临床试验中报告不足的不良事件:IMPALA (公司间质量分析) 联盟的实施和验证

Björn Koneswarakantha¹, Ronojit Adyanthaya², Jennifer Emerson³

¹F. Hoffmann-La Roche AG, 4070, Basel, Switzerland.

Therapeutic innovation & regulatory science

|April 2, 2024

概括

一个开源的R包,simarep,有效地检测在临床试验中不充分报告的不良事件 (AE). 该工具通过提供快速,全面和近乎实时的现场级AE报告分析来提高数据完整性和患者安全.

科学领域:

临床试验方法论临床试验方法论
药物监督药物监督药物监督
在医疗保健中的数据科学.

背景情况:

准确的不良事件 (AE) 报告对于临床试验完整性和患者安全至关重要.
对AE报告不足仍然是一个重大挑战,在良好的临床实践 (GCP) 审计中经常被发现.
目前的方法,如手动源数据验证 (SDV),在有效检测AE报告不足方面存在局限性.

研究的目的:

引入和验证开源R包,simarep,用于检测AE报告不足.
评估软件包在现场层面快速,全面,近乎实时地检测AE报告不足的能力.
评估simarep的性能与传统方法和启发式方法相比.

主要方法:

开发开源R包,simarep,利用患者级AE和访问数据.
由IntercoMPany quALity Analytics (IMPALA) 财团的三个成员公司对simarep包进行独立验证.
与启发式方法对比 simaerep 的检测率的比较分析.

主要成果:

simaerep在所有三家验证公司中一致有效地确定了AE报告不足.
与启发式方法相比,该包显示出更高的检测率.
在研究持续时间的25%标志上,simaerep确定了50%的可检测部位.

结论:

simaerep R包提供了一个强大的解决方案,用于识别临床试验中AE报告不足的情况.
它的整合到审计中有助于快速,整体和可重复的质量监督.
该工具通过及时检测AE显著提高了通过及时检测AE确保数据完整性和患者安全的能力.

关键词:

分析分析分析分析在GCP中,GCP是指GCP的指标.这是开源的,开源的.质量保证质量保证质量保证透明度透明度透明度验证验证验证验证

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