一项关于在德国从各个领域进行的干预和观察研究中遵守研究注册的观察性研究
Christian Thiele1, Gerrit Hirschfeld1
1University of Applied Sciences and Arts Bielefeld, Bielefeld, Germany.
PeerJ
|October 2, 2023
概括
临床试验注册与发表文章之间的差异仍然很大. 通过使用ClinicalTrials.gov改进了对临床试验注册的遵守,但不是临床研究协调中心 (KKS).
科学领域:
- 临床研究方法论临床研究方法论
- 科学出版物的完整性科学出版物完整性
背景情况:
- 研究注册是道德准则和期刊政策的强制要求.
- 发表的试验数据与其注册之间存在重大差异.
- 这项研究调查了德国招聘研究中的差异.
研究的目的:
- 评估研究注册与德国研究发表文章之间的差异.
- 检查注册坚持和临床研究协调中心 (KKS) 和卓越大学的参与之间的关联.
主要方法:
- 分析了376项干预或观察性研究注册和115篇相应的发表文章.
- 系统地寻找研究设计,纳入标准,干预,盲目和结果中的差异.
- 回归建模用于识别与遵守注册相关的因素.
主要成果:
- 在26%的研究中发现了差异,最常见的是次要结果 (16.5%).
- 在clinicaltrials.gov注册与更好的遵守有显著的关联.
- 参与KKS显示了积极的,但在统计学上不显著的关联与坚持.
结论:
- 临床试验注册和出版物之间的差异率仍然是一个重大问题.
- 临床试验.gov注册与改善的遵守有关.
- 需要进一步努力,以提高试验方案和公布结果之间的一致性.
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