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[临床试验注册——一次关键的评估]

[Registries for clinical trials -- a critical stock-taking].

作者信息

Bestehorn Kurt, Hönig Reinhard, Clemens Norbert, Kirch Wilhelm

机构信息

Institut für Klinische Pharmakologie, Medizinische Fakultät Carl Gustav Carus, Technische Universität, Dresden.

出版信息

Med Klin (Munich). 2006 Feb 15;101(2):120-6. doi: 10.1007/s00063-006-1017-9.

Abstract

A German working group had requested to introduce a national clinical trials registry. Keeping in mind the numerous existing German clinical trials registries requirements of such a registry, as well as the current international harmonization initiatives and the possibility of creating such a national registry were considered. To avoid multiple recording especially in regard to multicentric, international trials, it is recommended -- based on the spirit of the WHO recommendations -- to use the trial registry of the National Institutes of Health. For the time being, this trial registry represents the by far most frequently used database available for public use. It is equipped by internationally active pharmaceutical companies as well as universities and research facilities from all over the world and actually contains approximately 23,500 clinical studies. A national clinical trials registry could be installed at best only complementary and would have to get its data directly from the international registry without additional burden by research facilities.

摘要

一个德国工作组曾要求设立一个国家临床试验登记处。考虑到德国现有的众多临床试验登记处,这样一个登记处的要求,以及当前的国际协调倡议,并探讨了设立这样一个国家登记处的可能性。为避免重复记录,特别是对于多中心国际试验,根据世界卫生组织建议的精神,建议使用美国国立卫生研究院的试验登记处。目前,这个试验登记处是迄今为止最常用的可供公众使用的数据库。它由国际活跃的制药公司以及来自世界各地的大学和研究机构提供数据,目前大约包含23500项临床研究。国家临床试验登记处充其量只能作为补充设立,并且必须直接从国际登记处获取数据,而不给研究机构增加额外负担。

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