Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
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DOI：
10.1136/bmj.330.7497.956
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发表时间：
2005-04-23
影响因子：
105.7
通讯作者：
Gluud, C
中科院分区：
文献类型：
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作者：
Krleza-Jeric, K;Chan, AW;Gluud, C
最近有证据表明，选择性报告结果削弱了公众和学术界对临床试验出版物的信心，导致重新要求试验注册。1-5不公开试验结果的危险，尽管多年来一直在描述，但在去年春天发表了两篇关于选择性5-羟色胺再摄取抑制剂对儿童抑郁症影响的系统性综述后，引发了国际轰动。1 6随后的法律的程序7和期刊编辑、8 9医学协会10和行业11的政策声明已经认识到试验注册的重要性。登记试验的理由众所周知（方框1）。12 13最重要的是，当所产生的知识仍然不为人所知时，证明对人类参与者进行研究是合理的对社会公益的贡献就没有实现，作为一个对其资助的试验进行登记的感兴趣和中立的一方，14加拿大卫生研究所于2004年10月4日在加拿大渥太华主办了一次公开会议，以促进关于试验登记的国际共识。由此产生的渥太华声明旨在确立国际公认的登记原则（框2）。完整的声明在bmj上。但在这里，我们强调并讨论一些关键原则。关于如何执行这些原则的声明（第2部分）仍在拟订中。
Recent evidence of selective reporting of results has eroded public and academic confidence in publications of clinical trials, leading to renewed calls for trial registration. 1–5 The dangers of non-disclosure of trial results, although described for years, sparked an international furore last spring after the publication of two systematic reviews on the effects of selective serotonin reuptake inhibitors for childhood depression. 1 6 Subsequent legal proceedings7 and policy statements by journal editors, 8 9 medical associations, 10 and industry11 have recognised the importance of trial registration. The rationale for registering trials is well known (box 1). 12 13 Most importantly, the contribution to social good that justifies research on human participants is not realised when resulting knowledge remains invisible.As an interested and neutral party that has been registering the trials that it funds, 14 the Canadian Institutes of Health Research hosted an open meeting on 4 October 2004 in Ottawa, Canada, to foster international consensus on trial registration. The resulting Ottawa statement aims to establish internationally recognised principles for registration (box 2). The full statement is on bmj. com, but here we highlight and discuss some of the key principles. A statement on how to implement these principles (part 2) is still in development.