瘤学QCARD倡议:促进对初始现实世界数据提案的有效评估
Donna R Rivera1, Joy C Eckert2, Carla Rodriguez-Watson2
1Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Pharmacoepidemiology and drug safety
|October 28, 2024
概括
瘤学QCARD倡议制定了一个框架,用于评估瘤学研究的真实数据 (RWD) 质量. 这确保RWD适合使用,研究设计适合用于可靠的决策.
科学领域:
- 在瘤学瘤学.
- 现实世界的数据 (RWD) 分析分析.
- 医疗信息学 医疗信息学
背景情况:
- 瘤学质量,特征和评估现实世界数据 (QCARD) 倡议解决了在瘤学研究中对现实世界数据 (RWD) 进行强有力的评估的需求.
- 确保RWD来源的质量和适用性对于可靠的临床研究概念和决策至关重要.
研究的目的:
- 开发最少的研究设计和数据元素,以评估RWD源的适用性.
- 为了促进研究赞助商和科学审稿人之间关于RWD研究提案的早期互动.
主要方法:
- 一个多学科的执行委员会指导了这一倡议.
- 对文献,指南和指导方针进行了全文审查,以确定数据质量维度.
- 专家反为瘤QCARD初始协议表征 (IPC) 的开发提供了信息.
主要成果:
- 适合使用的数据 (相关和可靠) 和适合目的的设计 (确保有效性和透明度) 成为关键主题.
- 该QCARD-IPC概述了描述RWD研究概念的基本要素,涵盖数据时间性,人群,暴露,比较量,共变量,终点和质量保证.
结论:
- 评估RWD研究需要了解数据来源,设计和潜在的偏见,以确定适用性.
- 瘤学QCARD-IPC提供了一种结构化,透明的方法,用于初步审查和改善RWD研究提案的沟通.
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