Fate of biomedical research protocols and publication bias in France: retrospective cohort study
Fate of biomedical research protocols and publication bias in France: retrospective cohort study
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DOI：
10.1136/bmj.38488.385995.8f
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发表时间：
2005-07-02
影响因子：
105.7
通讯作者：
Chapuis, F
中科院分区：
文献类型：
--
作者：
Decullier, E;Lheritier, V;Chapuis, F
目的描述由法国研究伦理委员会批准的方案的命运，该委员会是由法国1988年《赫里耶-塞鲁斯克拉法》创建的一个国家系统;在国家一级评估发表偏倚。设计回顾性队列研究。设置1994年25/48个法国研究伦理委员会的代表性样本。协议649个委员会批准的研究协议，主要结果测量方案的初始特征（设计、研究规模、研究者）摘自委员会档案;随访信息（入学率、完成率、结果649/976例（69%）方案完成问卷调查。其中，581项（90%）研究已启动，501/581（86%）已完成，190/501（38%）已发表。具有确证性结果的研究比具有不确定性结果的研究更有可能作为科学论文发表（校正比值比4.59，95%置信区间2.21至9.54）。此外，验证性结果的研究发表更快，比不确定的结果的研究（风险比2.48，1.36至4.55）。结论在国家一级，太多的研究没有完成，其中完成了太多没有发表。我们建议利用研究伦理委员会，在系统和前瞻性的基础上登记和跟踪所有授权的人类参与者研究。
Objectives To describe the fate of protocols approved by the French research ethics committees, a national system created by the French 1988 Huriet-Serusclat Act; to assess publication bias at a national level.Design Retrospective cohort study.Setting Representative sample of 25/48 French research ethics committees in 1994.Protocols 649 research protocols approved by committees, with follow-up information.Main outcome measures Protocols' initial characteristics (design, study size, investigator) abstracted from committees' archives; follow-up information (rates of initiation, completion, and publication) obtained from mailed questionnaire to principal investigators.Results Completed questionnaires were available for 649/976 (69%) protocols. Of these, 581 (90%) studies were initiated, 501/581 (86%) were completed, and 190/501 (38%) were published. Studies with confirmatory results were more likely to be published as scientific papers than were studies with inconclusive results (adjusted odds ratio 4.59, 95% confidence interval 2.21 to 9.54). Moreover, studies with confirmatory results were published more quickly than studies with inconclusive results (hazard ratio 2.48, 1.36 to 4.55).Conclusion At a national level, too many research studies are not completed, and among those completed too many are not published. We suggest capitalising on research ethics committees to register and follow all authorised research on human participants on a systematic and prospective basis.