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在免疫媒介炎症疾病中使用外部控制臂:系统性审查
Alexa Zayadi1, Robert Edge1, Claire E Parker1
1Alimentiv Inc, London, Ontario, Canada.
BMJ open
|December 9, 2023
概括
在免疫媒介性炎症疾病 (IMIDs) 试验中的外部控制臂 (ECAs) 通常使用历史数据,缺乏标准化的方法. 制定报告准则可以提高研究的严谨性和透明度.
科学领域:
- 临床研究方法论临床研究方法论
- 免疫学 免疫学 免疫学
- 类风湿病学 类风湿病学
背景情况:
- 在随机对照有限的情况下,外部控制臂 (ECA) 在临床试验中是有价值的.
- 免疫媒介性炎症疾病 (IMIDs) 试验可以从ECA中获益,以获得比较有效的结果.
研究的目的:
- 系统地审查ECA在IMID临床试验中的应用.
- 评估IMID研究中使用的ECA的质量和方法.
主要方法:
- 在IMID试验中使用ECA的研究的系统审查 (炎症性肠道疾病,类风湿性关节炎,牛皮等). ) 的情况.
- 在五个领域中评估ECA源质量:数据收集,人口,结果,可靠性和全面性.
- 在Embase,Medline和Cochrane中央注册表中进行的搜索截至2023年9月.
主要成果:
- 43项研究符合纳入标准,主要是针对成年患者的单臂试验.
- 所有研究都使用了历史控制,而不是同时进行的ECA.
- 在RCT中,ECA通常来自其他RCT安慰剂组;在单臂试验中,历史病例系列很常见.
- 大多数研究 (31/43) 没有使用统计方法从历史数据中生成ECA.
结论:
- 在IMID试验中缺乏ECA的标准化方法和报告.
- 建议制定欧洲审计委员会的报告准则,以提高研究的严谨性和透明度.
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