对有关出版物提出的担忧的回复没有解决提出的担忧
Mark J Bolland1,2, Alison Avenell3, Andrew Grey1
1Department of Medicine, University of Auckland, Auckland, New Zealand.
British journal of pain
|December 18, 2023
概括
这项研究发现临床试验中报告的数据模式和基线p值存在差异,这表明随机化和数据完整性存在潜在问题. 对期刊提出的担忧仍未得到解决,使读者不了解关键数据问题.
科学领域:
- 临床试验方法论 临床试验方法论
- 在研究中的数据完整性.
背景情况:
- 人们对特定临床试验中的"不可靠数据"表示担忧.
- 之前的工作强调了来自特定研究小组的数据的潜在问题.
研究的目的:
- 检查特定研究小组的临床试验数据不一致性.
- 验证和报告随机化和报告的统计值的潜在问题.
主要方法:
- 分析报告的数据模式与预期有效随机化的偏差.
- 对类别变量报告的基线p值与独立计算的值进行比较.
主要成果:
- 在检查的试验中,确定了与有效的随机化不一致的数据模式.
- 发现分类变量基线p值的高比例与独立计算的值不同.
- 报告发现到期刊,但没有解决问题.
结论:
- 在调查的试验中存在重大数据完整性问题.
- 由于缺乏期刊行动,读者对关键数据问题没有了解.
- 关于试验数据完整性的未解决问题对科学透明度构成风险.
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