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低收入国家儿童临床试验中的实际问题:来自一线的经验。

Practical issues in relation to clinical trials in children in low-income countries: experience from the front line.

机构信息

College of Medicine, Paediatric Department, Blantyre, Malawi.

出版信息

Arch Dis Child. 2012 Sep;97(9):848-51. doi: 10.1136/archdischild-2011-301476. Epub 2012 Apr 13.

DOI:10.1136/archdischild-2011-301476
PMID:22504730
Abstract

Clinical trials in children in resource-poor environments are essential for local health policy and practice to be relevant and evidence based. Research must be ethical, appropriate, relevant and of good quality. It should, where possible, benefit the subjects studied,the clinical, scientific and support staff involved, and the service and academic institutions of the host country. The challenge for researchers and their sponsors is to maximise such benefits while avoiding the many possible pitfalls.

摘要

在资源匮乏环境下开展儿童临床试验对于使当地卫生政策和实践具有相关性并基于证据至关重要。研究必须符合伦理道德、适当、相关且高质量。在可能的情况下,它应该使研究对象、参与临床、科学和支持工作的人员以及所在国的服务和学术机构受益。研究人员及其资助者面临的挑战是在避免许多可能出现的陷阱的同时,最大限度地提高这些益处。

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