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开罗共识小组在随机临床试验中发表后完整性问题的国际多方利益相关者共识声明
Khalid Saeed Khan1, Mohamed Fawzy2, Patrick Chien3
1University of Granada, CIBERESP, Madrid, Spain.
概括
随机临床试验 (RCT) 由于不当行为指控而越来越多的撤回促使国际达成共识. 这项研究制定了出版后完整性的指导方针,旨在防止担忧并改善RCT中不当行为的调查.
科学领域:
- 临床试验 临床试验
- 研究诚信研究诚信
- 出版道德 出版道德
背景情况:
- 在全球范围内,随机临床试验 (RCT) 撤销的频率在公布后不当行为的指控之后正在上升.
- 这种趋势需要一种标准化的方法来解决完整性问题,并确保发表的研究的可靠性.
研究的目的:
- 建立国际多利益相关者共识,管理随机临床试验 (RCT) 特定的出版后完整性问题.
- 制定基于证据的政策和指导方针,以预防和调查RCT出版物中的不当行为指控.
主要方法:
- 89篇关于出版后完整性问题的文章的未来注册和证据综合.
- 来自18个国家的48名参与者组成的多学科利益相关者小组参与了两轮的德尔菲调查和混合共识开发会议.
- 在84个声明中达成共识,这些声明涵盖了研究诚信的各个方面,从期刊说明到调查协议.
主要成果:
- 在严格的德尔菲调查和共识会议之后,在84个声明上达成共识.
- 这些声明涉及一般的完整性方面,期刊政策,编辑流程,投诉处理,调查程序和制裁.
- 为批判性评估,RCT的系统审查和未来研究建议制定了具体的指导方针.
结论:
- 这一国际共识为旨在防止RCT发表后完整性问题的政策提供了框架.
- 制定的指导方针将有助于改善对不当行为指控的调查,从而提高研究的完整性.
- 共识声明是期刊,编辑,研究人员和参与RCT出版的机构的关键资源.
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