Division of Pulmonary and Critical Care, Curry International Tuberculosis Center, San Francisco General Hospital, University of California-San Francisco, CA 94110, USA.
Am J Respir Crit Care Med. 2011 Oct 15;184(8):972-9. doi: 10.1164/rccm.201105-0827WS.
The Centers for Disease Control and Prevention and National Institutes of Health convened a multidisciplinary meeting to discuss surrogate markers of treatment response in tuberculosis. The goals were to assess recent surrogate marker research and to provide specific recommendations for (1) the qualification and validation of biomarkers of treatment outcome; (2) the standardization of specimen and data collection for future clinical trials, including a minimum set of samples and collection time points; and (3) the creation ofa specimen repository to support biomarker testing. This article summarizes these recommendations and provides a roadmap for their implementation.
美国疾病控制与预防中心和美国国立卫生研究院召集了一次多学科会议,讨论结核病治疗反应的替代标志物。会议的目标是评估最近的替代标志物研究,并为以下方面提供具体建议:(1) 治疗结果生物标志物的资格和验证;(2) 未来临床试验标本和数据采集的标准化,包括最小样本集和采集时间点;(3) 创建一个标本库,以支持生物标志物检测。本文总结了这些建议,并提供了实施这些建议的路线图。