Global Alliance for TB Drug Development, Pretoria, South Africa.
Int J Tuberc Lung Dis. 2009 Nov;13(11):1367-72.
To assess clinical trial sites and associated mycobacteriology laboratories for their capacity to conduct registration-standard tuberculosis (TB) drug trials and develop a database of assessed sites and laboratories.
Assessments of clinical trial sites and associated mycobacteriology laboratories were conducted in 39 countries from 2006 to 2008.
Sites were interviewed using a set of questionnaires to assess the clinical site, pharmacy, data management, regulatory, ethics and importation requirements and mycobacteriology laboratory. Each site and laboratory was rated as able to conduct TB drug registration trials within 0-6 months, >6-12 months, >1-2 years and >2 years.
Eighty-four clinical trial sites and associated mycobacteriology laboratories in 39 countries were assessed. Of the clinical trial sites, 50% were judged capable of being ready within 6 months, 32.1% in 6-12 months and 14.3% in 1-2 years. Three sites would be ready in more than 2 years. Of the 72 mycobacteriology laboratories, 27.8% could be made ready within 6 months, 37.5% within 6-12 months and 27.8% within 1-2 years.
This survey indicates that developing adequate capacity to fully evaluate the compounds now in the clinical phases of development will require significant capacity-building efforts.
评估临床试验机构和相关分枝杆菌学实验室进行注册标准结核病（TB）药物试验的能力，并建立评估机构和实验室的数据库。
2006 年至 2008 年在 39 个国家进行了临床试验机构和相关分枝杆菌学实验室的评估。
使用一组问卷对临床机构、药房、数据管理、监管、伦理和进口要求以及分枝杆菌学实验室进行访谈。根据每个机构和实验室在 0-6 个月、>6-12 个月、>1-2 年和>2 年内进行 TB 药物注册试验的能力进行评分。
对 39 个国家的 84 个临床试验机构和相关分枝杆菌学实验室进行了评估。在临床试验机构中，50%的机构被认为在 6 个月内能够准备就绪，32.1%的机构在 6-12 个月内能够准备就绪，14.3%的机构在 1-2 年内能够准备就绪。有 3 个机构需要 2 年以上的时间才能准备就绪。在 72 个分枝杆菌学实验室中，27.8%的实验室可以在 6 个月内准备就绪，37.5%的实验室可以在 6-12 个月内准备就绪，27.8%的实验室可以在 1-2 年内准备就绪。
这项调查表明，要充分评估目前处于临床开发阶段的化合物，需要进行大量的能力建设。
