发表的3期随机癌症试验是否遵循常识瘤学提出的原则
Omar Abdihamid1, Bishal Gyawali2, Christopher M Booth3
1Garissa Regional Cancer Center, Garissa County Referral Hospital, PO Box 29, Garissa, 70100, Kenya; Division of Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, Kingston, ON, Canada.
概括
严格的癌症临床试验设计和报告至关重要. 对55项试验的审查发现了方法,终点选择和患者报告的结果和成本的报告方面的缺陷,突出了需要改进的领域.
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:
- 随机对照试验 (RCT) 对癌症治疗决策至关重要.
- 常识瘤学 (CSO) 为严格的RCT提供了原则和检查清单.
- 确保遵守CSO原则是可靠试验数据的关键.
研究的目的:
- 评估最近的RCT是否符合民间社会组织原则.
- 建立未来癌症临床试验质量的基准.
- 确定需要在试验设计,分析和报告方面改进的具体领域.
主要方法:
- 在55个RCT中系统地应用CSO检查清单.
- 评估的RCT于2023年发表,重点是固体瘤的全身疗法.
- 评估遵守设计,分析和报告的原则.
主要成果:
- 许多试验缺乏适当的对照组 (22%) 或替代初级终点 (60%) 的充分理由.
- 与健康相关的生活质量 (HRQoL) 作为次要终点未得到充分利用 (42%).
- 管理审查和退学的策略得到了很少的解决 (只有9%的人使用了灵敏度分析). 成本效益很少被报告 (3项试验).
结论:
- 对于实体瘤的RCT的设计,分析和报告存在重大缺陷.
- 需要在遵守解释试验结果的既定原则方面进行改进.
- 系统地应用CSO检查清单揭示了提高临床试验质量的关键领域.
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