癌症临床试验 患者对通过电子平台报告不良事件的看法
Minna Grahvendy1,2, Bena Brown3,4, Laurelie R Wishart5,6,7,8
1Cancer Trials Unit, Princess Alexandra Hospital, Queensland Health, Brisbane, QLD, Australia. minna.grahvendy@health.qld.gov.au.
Therapeutic innovation & regulatory science
|May 23, 2025
概括
癌症患者发现,报告不良事件的电子平台是可以接受和可行的. 建议对平台功能进行改进,以提高参与者的参与度并减少症状负担.
科学领域:
- 临床试验方法论 临床试验方法论
- 患者报告的结果
- 数字健康技术是数字健康技术.
背景情况:
- 准确的不良事件 (AE) 报告对于临床试验的成功至关重要.
- 越来越多的趋势是直接从患者那里收集AE数据.
- 这项研究研究了在癌症临床试验中使用基于网络的平台,用于患者在癌症临床试验中自我报告AE数据.
研究的目的:
- 探索癌症患者的感知和经验,使用电子平台自我报告不良事件数据.
- 评估患者在干预性临床试验环境中对AE数据的自我报告的可行性和可接受性.
主要方法:
- 在澳大利亚一家三级医院进行的干预性癌症临床试验中,符合条件的患者被录取.
- 参与者使用在线平台每周报告26周的症状数据.
- 通过在基线,第12周和第26周的实施调查,以及在第26周的定性访谈,收集了参与者的反.
主要成果:
- 在他们参与研究期间,参与者始终认为该平台是可接受的,适当的和可行的.
- 定性分析确定了关键主题:可访问性和可用性,平台功能以及个人利益/负担.
- 确定了需要改进的领域,主要涉及平台功能和管理症状负担,以保持参与者的参与.
结论:
- 这项研究提供了通过电子平台对参与者自我报告癌症临床试验AE数据的经验的深入见解.
- 这些发现支持先前关于从参与者的角度直接收集患者AE数据的可行性研究.
- 参与者认为该平台对未来的癌症临床试验参与者来说是可行的和有益的.
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