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在中国开展高质量的结核病临床试验:机遇与挑战。

Conducting high-quality tuberculosis clinical trials in China: opportunities and challenges.

机构信息

Tuberculosis Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.

出版信息

Int J Tuberc Lung Dis. 2017 Nov 1;21(11):1094-1100. doi: 10.5588/ijtld.17.0105.

Abstract

Tuberculosis (TB) is an ancient disease that is a devastating threat to public health. As the country with the second highest number of TB cases and the highest number of multidrug-resistant TB cases in the world, China is now striving to be at the forefront of TB research and drug development. This article is based on the observations made by the authors during the recent partnership initiative between the National Institutes of Health and the Chinese TB community, as well as an extensive literature review. The article examines the advantages and challenges of conducting large-scale international multicenter TB clinical trials in China. China is becoming an excellent location for new TB drug trials, especially in collaboration with international organizations that bring considerable technical assistance, quality control, training, and oversight with these partnerships.

摘要

结核病(TB)是一种古老的疾病,对公共卫生构成了毁灭性的威胁。中国是世界上结核病病例数第二高、耐多药结核病病例数最高的国家,目前正努力在结核病研究和药物开发方面处于领先地位。本文基于作者在最近美国国立卫生研究院与中国结核病界合作倡议期间的观察,以及广泛的文献回顾。本文探讨了在中国开展大规模国际多中心结核病临床试验的优势和挑战。中国正在成为新的结核病药物试验的理想地点,特别是与那些带来大量技术援助、质量控制、培训和监督的国际组织合作时。

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