Surrogate markers in AIDS clinical trials: conceptual basis, validation, and uncertainties.
Surrogate markers in AIDS clinical trials: conceptual basis, validation, and uncertainties.
复制标题
艾滋病临床试验中的替代标记：概念基础、验证和不确定性。
DOI：
10.1093/clinids/16.supplement_1.s22
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发表时间：
1993
期刊：
影响因子：
--
通讯作者：
Lagakos,SW
中科院分区：
文献类型：
--
作者：
Lagakos,SW
临床终点的替代标志物的鉴定对于艾滋病临床试验的进行、用于治疗人类免疫缺陷病毒（HIV）感染的药物的批准以及HIV感染的管理具有重要意义。本文讨论了替代标记的概念和理想标记的性质。经验验证一个潜在的标志物所需的步骤，然后解决，目前的信息艾滋病的替代标志物进行审查。迄今为止进行的研究表明，一种新药对CD4淋巴细胞数量的影响只能部分解释其对艾滋病毒感染临床进展的最终影响。因此，基于对CD4淋巴细胞的影响而早期批准药物的潜在益处必须与其实际延迟临床进展能力的不确定性进行权衡。
The identification of surrogate markers for clinical end points has important implications for the conduct of AIDS clinical trials, the approval of drugs for the treatment of infection with human immunodeficiency virus (HIV), and the management of HIV infection. In this paper, the concept of a surrogate marker and the properties of an ideal marker are discussed. The steps required for the empirical verification of a potential marker are then addressed, and current information on surrogate markers for AIDS is reviewed. Studies conducted to date indicate that the effects of a new drug on numbers of CD4 lymphocytes account only partly for its ultimate impact on the clinical progression of HIV infection. Consequently, the potential benefits of early approval of a drug based on its effect on CD4 lymphocytes must be weighed against the uncertainty about its ability to actually delay clinical progression.