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古巴临床试验公共登记处:世界卫生组织的主要登记处。

The Cuban Public Registry of Clinical Trials: primary registry of World Health Organization.

机构信息

National Coordinating Centre of Clinical Trials, La Habana, Cuba.

出版信息

J Evid Based Med. 2011;4(3):161-4. doi: 10.1111/j.1756-5391.2011.01140.x.

Abstract

Despite the importance of randomized trials for well-informed decisions in health care, a large proportion of the results of these trials are not published, especially when they are negative. Publication bias has a negative impact in the treatment of patients, due to the distorted impression it leads to for new therapies. Clinical Trial Registries help to overcome this by providing transparency in the process of conducting research. The World Health Organization takes the position that the registration of interventional trials is a scientific, ethical and moral responsibility. Taking account of this global movement, the National Coordinating Centre of Clinical Trials and the Cuban Health Network, designed and implemented the Cuban Public Registry of Clinical Trials. The Registry was established in June 2007 and is intended for public service in Cuban territory, although it is open to registrants and patients outside Cuba. The Registry staff developed a strategy to become a Primary Registry of the World Health Organization, and this was achieved in February 2011.

摘要

尽管随机试验对于医疗保健中的明智决策至关重要,但这些试验的结果中有很大一部分并未发表,尤其是当结果为阴性时。发表偏倚会对患者的治疗产生负面影响,因为它会导致对新疗法的印象扭曲。临床试验注册中心通过提供研究过程的透明度来帮助克服这一问题。世界卫生组织认为,干预性试验的注册是一种科学、伦理和道德责任。考虑到这一全球运动,国家临床试验协调中心和古巴卫生网络设计并实施了古巴临床试验公共注册中心。该注册中心于 2007 年 6 月成立,旨在为古巴境内的公众服务,尽管它也向古巴境外的注册者和患者开放。该注册中心的工作人员制定了一项成为世界卫生组织主要注册中心的战略,并于 2011 年 2 月实现了这一目标。

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