实施研究参与者反问卷,以了解参与者在癌症临床试验第三阶段的经验
Andrzej Nowojewski1, Alex Wheal2, William Dott3
1R&D BioPharmaceuticals, AstraZeneca, Cambridge, England, UK andrzej.nowojewski@astrazeneca.com.
BMJ open
|October 28, 2025
概括
参与INTERLINK-1临床试验的参与者报告了使用研究参与者反问卷 (SPFQ) 的整体积极经验. 性,大陆和不良事件等因素影响了他们的试验旅程的特定方面.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- INTERLINK-1试验 (NCT04590963) 是一个第三期,随机,双盲,安慰剂控制的多中心研究.
- 这项研究在21个国家的79个地点招募了371名患有复发性/转移性头角状细胞癌的成年人.
研究的目的:
- 通过研究参与者反问卷 (SPFQ) 评估参与者在INTERLINK-1临床试验中的经验.
- 确定与参与者经验相关的因素,并评估SPFQ的实施情况.
主要方法:
- 研究参与者反问卷 (SPFQ) 在注册时 (SPFQ-A),在试验期间 (SPFQ-B) 和完成时 (SPFQ-C) 进行.
- 使用顺序回归模型分析与患者体验相关的因素,考虑潜在的偏差.
主要成果:
- 超过80%的参与者报告说,在招生,地点和整体试验方面都有积极的经验.
- 男性性别,亚洲大陆,最近的不良事件和更高的ECOG绩效状态与较少的积极体验有关.
- 注意到了默许偏见,可能是由于SPFQ问题设计.
结论:
- 参与者在INTERLINK-1试验中总体上报告了积极的体验,通过SPFQ测量.
- 经验的变化与人口和临床因素有关,需要进一步调查.
- 结果将为未来的SPFQ实施和改善公平试验经验的策略提供信息.
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