SISAQOL-IMI基于共识的指导方针,用于设计,分析,解释和呈现癌症临床试验中患者报告的结果
Cecilie D Amdal1, Ragnhild S Falk1, Ahu Alanya2
1Oslo University Hospital, Oslo, Norway.
The Lancet. Oncology
|November 27, 2025
概括
制定在癌症临床试验中分析患者报告结果和生命质量终点的国际标准 - 创新药物倡议 (SISAQOL-IMI) 制定了146条建议,以标准化癌症临床试验中患者报告结果 (PRO). 这些指南旨在改善对癌症治疗的好处和风险的评估.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 标准化患者报告结果 (PROs) 对于强大的癌症临床试验评估至关重要.
- 在试验中实施PRO的现有方法缺乏一致性,阻碍了比较分析.
- 在癌症临床试验-创新药物倡议 (SISAQOL-IMI) 中分析患者报告结果和生命质量终点的国际标准的制定是为了弥补这个差距而建立的.
研究的目的:
- 开发和传播基于共识的建议,用于在癌症临床试验中标准化实施PRO.
- 提供全面的指导,涵盖PRO的整个生命周期,从设计到呈现.
- 提高使用PROs.的癌症临床试验产生的证据的质量和可比性.
主要方法:
- 一个涉及统计,PRO测量,临床实践和患者倡导的专家的多方利益相关者倡议.
- 通过结构化流程制定146项基于共识的建议.
- 跨41个组织的合作,包括监管机构,学术界,行业和患者团体.
主要成果:
- 在癌症临床试验中设计,分析,解释和呈现PRO的一整套146条建议.
- 在各种试验设计 (随机对照试验,单臂试验) 中实施PRO的指导.
- 开发支持资源,包括交互式表,指南,普通语言材料和词汇表.
结论:
- SISAQOL-IMI建议为癌症临床试验中的PRO提供了一个标准化的框架.
- 这些标准的实施将提高PRO数据的一致性和有效性.
- 这些成果促进了PROs采用最佳实践,最终使癌症患者受益.
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