对宫癌或前癌症的随机对照试验的中止和不公布
Dongfang Lu1, Xiaolin Chen1, Yanmin Mu1
1Department of Gynecology, Xingtai Central Hospital, Xingtai 054000, China.
Japanese journal of clinical oncology
|July 23, 2024
概括
许多用于宫癌研究的随机对照试验 (RCT) 提前中止或从未发表,导致大量的研究浪费. 诸如单一中心设计和缺乏外部资金等因素导致了这个问题.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 研究方法研究方法研究方法学
背景情况:
- 研究浪费是临床试验中的一个重要问题,非出版是其中的主要原因.
- 了解试验中止和未发表的流行情况对于提高研究效率至关重要.
研究的目的:
- 确定以宫癌或癌前期为重点的随机对照试验 (RCT) 的过早停止和未发表的患病率.
- 确定与试验中止和未发表在该领域的相关因素.
主要方法:
- 我们对ClinicalTrials.gov进行了系统的搜索,寻找2000年1月至2020年12月期间开始的宫癌或癌前期癌症的RCT.
- 通过搜索PubMed和Scopus数据库来验证出版状态.
- 试验中止和未发表被评估为主要和次要结果,分别.
主要成果:
- 在包括的113个RCT中,44%的已完成试验过早停止,而47.1%的试验仍未发表.
- 单一中心设计和缺乏外部资金与试验中止有显著的关联.
- 大规模试验 (样本大小>400) 和获得外部资助的试验更有可能被公布,大样本大小和外部资金是公布的独立积极预测因素.
结论:
- 很多宫癌和癌前期的RCT都面临着早期停药或未发表的情况.
- 这导致大量浪费宝贵的研究资源.
- 促进大规模,外部资助的试验可能有助于提高出版率和减少研究浪费.
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