结果报告在临床试验中的偏见,研究多发性硬化症患者的疾病修饰疗法
Cynthia M C Lemmens1, Suzan van Amerongen1, Eva M Strijbis1
1From the Department of Neurology (C.M.C.L.), Haaglanden Medical Center, The Hague; and Department of Neurology (S.A., E.M.S., J.K.), Amsterdam Neuroscience, Amsterdam UMC, Vrije Universiteit Amsterdam, The Netherlands.
Neurology
|February 26, 2024
概括
选择性结果报告偏见在多发性硬化症 (MS) 临床试验中很常见,其中95%显示注册和公布结果之间的差异. 这种偏见影响了MS研究中免疫调节药物的研究结果的有效性.
科学领域:
- 临床试验方法论 临床试验方法论
- 神经学 神经学
- 药学研究 药学研究
背景情况:
- 结果报告偏差,即试验公布取决于临床意义,损害了研究有效性.
- 针对多发性硬化症 (MS) 的免疫调节药物研究已显著扩大.
- 在MS免疫调节药物试验中评估结果报告偏差至关重要.
研究的目的:
- 调查多发性硬化症 (MS) 临床试验中结果报告偏差的程度.
- 确定在免疫调节药物研究中导致这种偏差的潜在因素.
主要方法:
- 在ClinicalTrials.gov上注册的识别的MS临床试验 (2007年9月以后,2019年之前).
- 从注册表中提取了研究设计,资金和结果数据.
- 将注册的结果与公布的结果进行比较,以检测差异.
主要成果:
- 在535项试验中,101项有出版物;95%的结果显示报告不一致.
- 26个出版物在主要结果中存在差异;44%的公布次要结果没有被注册.
- 迟到的注册和结果修改是常见的;非行业和开放标签试验显示了偏见的趋势.
结论:
- 选择性结果报告在MS的疾病修饰药物试验中非常普遍.
- 为了提高研究完整性,需要采取减轻结果报告偏差的策略.
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