摘要
目的临床试验类研究论文大多由公司申办或者受到公司资助，其在发表时不可避免地存在潜在的发表偏倚，该文探讨临床试验类研究论文中所涉及的作者和作者署名以提示相关研究者。方法通过对公司申办的临床试验发表指南（Good Publication Practice for pharmaceutical companies，GPP）第三版进行解读，并结合文献和国内相关政策进行分析。结果临床试验类研究论文中的作者和作者署名涉及如何处理好设立出版指导委员会、明确作者署名、聘请专业医学撰稿人、资助费用、作者贡献说明和致谢、潜在的利益冲突和作者的权利和义务等问题。结论参与临床试验的研究者在临床试验结果发表时应当谨慎对待作者和作者署名的相关问题。
Objective Clinical trial researches are sponsored by medical companies mostly, the research paper publishes in a potential publication bias inevitably. This paper discussed the author＇s and authorship＇s issues in clinical trials. Methods The Good Publication Practice for pharmaceutical companies （GPP） 3rd edition was interpreted, related literatures and domestic policies were analyzed. Results The issues including setting up publication steering committees, clarifying authorship, employing professional medical writers, personal fees, contributorship and acknowledgments, potential conflict of interest, and author＇s rights and obligations should be well panned and deal with in clinical trials. Conclusions Researchers who involved in clinical trials should treat the author＇s and authorship ＇s issues with caution.
出处
《中华医学科研管理杂志》
2017年第5期330-333,共4页
Chinese Journal of Medical Science Research Management
关键词
临床试验
公司申办
发表偏倚
Clinical trial
Company sponsor
Publication bias
