在ClinicalTrials.gov注册的未公布完成的产科随机临床试验:这个问题有多大?
Megha Gupta1, Emily A Oliver2, Suneet P Chauhan3
1Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA (Drs Gupta and Wagner); Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA (Drs Gupta and Wagner).
American journal of obstetrics & gynecology MFM
|July 7, 2023
概括
超过40%的已完成的产科随机临床试验仍未发表. 缺乏时间和较小的研究规模被认为是公布这些重要的临床研究结果的关键障碍.
科学领域:
- 产科和妇科 产科和妇科
- 临床试验 研究 研究 临床试验 临床试验
- 出版道德 出版道德
背景情况:
- 在ClinicalTrials.gov上注册的大量产科随机临床试验 (RCT) 并未在同行评审期刊上发表.
- 这凸显了在产科领域传播研究成果的差距.
研究的目的:
- 为了比较已完成的已发表与未发表的产科RCT的特征.
- 确定阻碍这些试验发表的主要障碍.
主要方法:
- 一项横截面研究分析了来自ClinicalTrials.gov (2009-2018) 的647个已完成的产科RCT.
- 使用PubMed和谷歌学者来确定出版状况.
- 对未发表试验的作者进行了一项调查,以确定出版障碍.
主要成果:
- 在已完成的647项试验中,58%已发表,42%仍未发表.
- 未公布的试验规模较小 (注册人数<50) 并不太可能在多个地点进行.
- 主要障碍包括缺乏时间 (30%),职业转变 (25%) 和非显著的结果 (15%).
结论:
- 超过40%的已完成的产科RCT没有发表,这意味着大量的研究数据丢失.
- 较小的试验规模和缺乏时间是产科研究人员出版的重大障碍.
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