在癌症临床试验中的实用主义
Kamya Sankar1, Mary W Redman2,3, Konstantin H Dragnev4
1Cedars-Sinai Medical Center, Los Angeles, CA.
概括
实用试验通过在现实环境中评估癌症治疗来增强瘤学研究. 将实用特征集成到临床试验中可以提高概括性和患者的结果.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 传统的解释性癌症临床试验往往缺乏现实世界的概括性.
- 试验复杂性的增加导致协议偏差,入学速度缓慢,成本更高.
- 实用试验评估在常规护理下代表性人群中的干预措施.
研究的目的:
- 审查瘤学临床试验中实用特征的原则,方法,挑战和优势.
- 为了说明实用性试验设计在癌症研究中的应用.
- 倡导将现实实践纳入临床试验,以改善患者的治疗结果.
主要方法:
- 对实用试验的原则和方法的审查.
- 讨论将务实特征纳入的挑战和优势.
- 通过QUASAR,TAPUR和PRAGMATICA-LUNG等案例研究进行说明.
主要成果:
- 实用试验在现实条件下评估干预的有效性.
- 实用特征的整合提高了通用性和适用性.
- 像Pragmatica项目这样的倡议促进了现实世界的整合.
结论:
- 在可行的情况下,结合实用性特征,可以提高瘤学临床试验的现实应用性.
- 衡量有效性和有效性的平衡方法至关重要.
- 最终目标是通过更相关的研究来改善患者的治疗结果.
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