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癌症临床试验中的核心成果集:当前状态和未来的机会 - - 一个EORTC视角
Ailbhe Lawlor1, Steven MacLennan2, Jan Bogaerts3
1Transforming Cancer Outcomes Through Research (TOUR), King's College London, London, UK. ailbhe.lawlor@kcl.ac.uk.
Trials
|April 9, 2025
概括
核心结果集 (COS) 标准化了临床试验报告. 虽然可用于许多癌症,但只有10%的受访欧洲癌症研究和治疗组织 (EORTC) 成员使用它们,原因是结果数量和时间限制等障碍.
科学领域:
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
- 瘤学研究研究
背景情况:
- 在临床试验中报告不一致的结果是一个重大挑战.
- 核心成果集 (COS) 旨在标准化特定健康领域的成果测量和报告.
- 本研究重点关注癌症特异性COS及其在临床试验中的采用.
研究的目的:
- 审查现有的癌症特异性核心结果集 (COS).
- 评估欧洲癌症研究和治疗组织 (EORTC) 试验者的COS意识和使用情况.
- 确定在癌症临床试验中实施COS的障碍.
主要方法:
- 探索性,横截面的研究设计.
- 对癌症COS的有效性试验 (COMET) 核心结果测量数据库的系统搜索.
- 在线调查分发给EORTC成员,以衡量COS的认识和使用情况.
主要成果:
- 在COMET数据库中发现了85个与癌症相关的COS;69个与EORTC分类相关.
- 在710名EORTC受访者中,有一半不知道COS.
- 只有10%的受访者利用了可用的COS,并将结果数量,时间和基础设施列为关键障碍.
结论:
- 癌症COS越来越多,但实施仍然有限.
- 需要进一步开发以解决缺失的瘤类型,并更多地让试验者参与COS创建.
- 提高对COS的认识和理解对于在癌症临床试验中广泛采用至关重要.
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