Bridging the gap: moving predictive and prognostic assays from research to clinical use.
Bridging the gap: moving predictive and prognostic assays from research to clinical use.
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DOI：
10.1158/1078-0432.ccr-11-2203
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发表时间：
2012-03-15
期刊：
影响因子：
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通讯作者：
Conley BA
中科院分区：
文献类型：
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作者：
Williams PM;Lively TG;Jessup JM;Conley BA
临床有用的分子诊断学的发展需要在临床试验中验证临床分析性能和取得临床资格。正如在分子诊断学焦点部分的其他地方所讨论的那样，检测性能的验证必须是严格的，特别是当检测将被用于指导治疗决策时。在这里，我们回顾了与分析发展相关的一些问题或障碍，特别是对于学术研究人员。这些问题包括缺乏分析验证的专业知识和资源，缺乏针对特定临床用途的项目设计经验，缺乏来自适当患者群体的样本，以及缺乏获得临床实验室改进法案(CLIA)认证的实验室。此外，对化验验证的财政支持落后于对标记物发现或药物开发的财政支持，尽管分子诊断可能被认为是成功使用伴随疗法所必需的。国家癌症研究所支持大量的临床试验和药物开发方面的重大努力。为了解决预测和预后分析中的一些障碍，这些障碍将用于临床试验，以选择特定治疗的患者，将患者分成分子定义的亚组，或者在分子定义的肿瘤的治疗之间进行选择，美国国家癌症研究所(NCI)已经启动了一项试点计划，旨在减少开发经过验证的预后和预测分析的障碍。
The development of clinically useful molecular diagnostics requires validation of clinical assay performance and achievement of clinical qualification in clinical trials. As discussed elsewhere in this Focus Section on Molecular Diagnostics, validation of assay performance must be rigorous especially when the assay will be used to guide treatment decisions. Here we review some of the problems or hurdles associated with assay development, especially for academic investigators. These include lack of expertise and resources for analytical validation, lack of experience in project design for a specific clinical use, lack of specimens from appropriate patient groups, and lack of access to Clinical Laboratory Improvement Act (CLIA) certified laboratories. In addition, financial support for assay validation has lagged behind financial support for marker discovery or drug development, even though the molecular diagnostic may be considered necessary for the successful use of the companion therapeutic. The National Cancer Institute supports a large number of clinical trials and a significant effort in drug development. In order to address some of these barriers for predictive and prognostic assays that will be used in clinical trials to select patients for a particular treatment, stratify patients into molecularly defined subgroups, or choose between treatments for molecularly defined tumors, the National Cancer Institute (NCI) has begun a pilot program designed to lessen barriers to the development of validated prognostic and predictive assays.