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临床试验注册:从预兆到普遍公开的实践。

Clinical trial registries: from an omen to a common and disclosed practice.

机构信息

Department of Public Health, IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Via Giuseppe la Masa 19, 20156 Milan, Italy.

出版信息

Eur J Clin Pharmacol. 2013 Sep;69(9):1725-6. doi: 10.1007/s00228-013-1526-4. Epub 2013 May 19.

Abstract

OBJECTIVE

Clinical trials registries are important for guaranteeing trustworthy scientific knowledge. Despite international initiatives promoting trial registration, however, complete and high quality disclosure of trial information in such registries is not routine. The role of registries in also increasing transparency is fundamental, and these databases could be contemplated by research organizations, even at more local levels.

METHODS

A rare initiative was set up at the IRCCS-Mario Negri Institute for Pharmacological Research in Milan in order to make the institute's ongoing research accessible to anyone.

RESULTS

The register currently includes 112 studies in which the institute participates.

CONCLUSIONS

Work still needs to be done to improve the registry, but it is up and functional. Could, or should, such registries be routine for all scientific institutions?

摘要

目的

临床试验注册对于保证可靠的科学知识至关重要。尽管有国际倡议推动试验注册,但此类注册处仍未常规完整且高质量地披露试验信息。注册处对提高透明度也具有重要作用,研究机构甚至在更局部的层面上都可以考虑使用这些数据库。

方法

米兰马里奥·内格里药理研究所(IRCCS-Mario Negri Institute for Pharmacological Research)采取了一项罕见的举措,旨在让任何人都能访问研究所正在进行的研究。

结果

该注册处目前包含研究所参与的 112 项研究。

结论

虽然还有改进该注册处的工作要做,但它已经上线并开始运行。所有科学机构都应该或者可能需要这样的注册处吗?

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