癌症临床试验中患者退出,保留策略和退出后数据实践的记录
Alexander B Karol1, Rodrigo Paredes2, Anna Argulian3
1Division of Hematology and Medical Oncology, The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Cancer
|September 26, 2025
概括
许多患者在没有明确原因的情况下退出癌症临床试验,这影响了研究的有效性. 标准化戒断文档和数据保留对于可靠的癌症研究至关重要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 由于未明确的原因,患者退出癌症试验引入了偏见,并降低了概括性.
- 缺乏撤回的明确理由可以掩盖治疗的毒性或膨胀疗效.
- 对试验完整性存在担忧,原因是对记录和保留退出数据的监管指南的不一致遵守.
研究的目的:
- 在癌症临床试验的第三阶段,确定患者在没有特定理由的情况下退出癌症的患病率.
- 评估对退出试验的患者实施保留策略的执行情况.
- 评估癌症临床试验中患者退出后的数据保留实践.
主要方法:
- 一项横截面研究分析了在ClinicalTrials.gov (2014-2024) 上注册的300项已完成的癌症第三期临床试验.
- 试验评估了全身或局部抗癌疗法,并有可用的方案.
- 主要结果:患者在没有具体理由的情况下退出的比例;次要结果:保留策略和退出后数据实践的流行率.
主要成果:
- 在165,674名注册患者中,有15.8%的患者在没有具体理由的情况下退出.
- 虽然协议要求记录退出原因,但平均7.5%的退出缺乏具体的理由.
- 在68.0%的协议中没有保留策略,32.3%的协议中缺乏关于退出后数据保留的清晰度.
结论:
- 很大一部分患者在没有证据的理由下退出癌症第三阶段试验.
- 在记录退出和在退出后保留数据方面不一致的做法需要标准化的方法.
- 提高试验质量需要标准化的方法来管理患者退出和相关数据.
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