在随机试验期间改变护理标准:例子,考虑和指导方针
Boris Freidlin1, Malcolm A Smith2, Carmen J Allegra2,3
1Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Journal of the National Cancer Institute
|January 25, 2026
概括
随机临床试验 (RCT) 评估新的癌症治疗方法,但在试验期间改变护理标准 (SOC) 可能会影响结果. 需要策略来设计试验,以尽量减少这些动态的SOC效应,以可靠地评估癌症治疗.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 随机临床试验 (RCT) 对于评估新的癌症治疗方法至关重要.
- 随机试验的有效性依赖于反映当前护理标准 (SOC) 的控制臂.
- 癌症治疗的快速进步导致在正在进行的试验中SOC经常发生变化.
研究的目的:
- 检查动态护理标准 (SOC) 对正在进行的随机临床试验 (RCT) 的影响.
- 为在不断变化的癌症治疗环境背景下设计和进行RCT提供建议.
- 确保RCT结果的持续临床相关性和准确解释.
主要方法:
- 对随机临床试验 (RCT) 期间护理标准 (SOC) 发生变化的常见场景的审查.
- 分析动态SOC对试验进行和解释的潜在影响.
- 开发试验设计的前性策略,以减轻SOC相关的挑战.
主要成果:
- 在随机临床试验 (RCT) 期间改变护理标准 (SOC) 可以引入偏见并影响结果的解释.
- 癌症治疗创新的加快速度加剧了在控制武器中保持相关的SOC的挑战.
- 积极的试验设计对于解决不断变化的SOC对RCT有效性的影响至关重要.
结论:
- 动态护理标准 (SOC) 对正在进行的随机临床试验 (RCT) 的完整性构成重大挑战.
- 实施适应性试验设计和前性策略可以帮助减轻改变SOC的影响.
- 解决这些方法问题对于产生癌症治疗进展的可靠证据至关重要.
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