Implementation of Validated Pharmacodynamic Assays in Multiple Laboratories: Challenges, Successes, and Limitations
Implementation of Validated Pharmacodynamic Assays in Multiple Laboratories: Challenges, Successes, and Limitations
复制标题
DOI：
10.1158/1078-0432.ccr-14-0476
复制
发表时间：
2014-05-15
影响因子：
11.5
通讯作者：
Parchment, Ralph E.
中科院分区：
文献类型：
--
作者：
Kinders, Robert;Ferry-Galow, Kate;Parchment, Ralph E.
药效学（PD）生物标志物检测有一个“生命周期”，指导我们实验室的开发和临床实施。生物标志物、标本采集、处理和分析方法的分析分析验证和适用性论证的公认要素只是所需活动的一部分。跨实验室的分析转移和对实际人类临床标本的测试对于理解分析性能和稳健性至关重要。根据我们的经验，这种以患者标本为中心的方法需要对分析方法进行修改，有些是出乎意料的，但这对于在临床试验中成功实施至关重要。此外，将检测分散到国家癌症研究所的临床试验网络中，需要开发校准器和对照材料以及正式的培训课程，以便顺利实施。这种方法成功的一个衡量标准是，NCI弗雷德里克国家实验室开发的许多检测方法最终达到了商业化阶段，使研究界能够广泛使用PD生物标志物检测方法。
There is a "life cycle" of pharmacodynamic (PD) biomarker assays that guides the development and clinical implementation in our laboratories. The well-recognized elements of analytical assay validation and demonstration of fitness-for-purpose of the biomarker, specimen collection, handling, and assay methods are only a part of the required activities. Assay transfer across laboratories and testing on actual human clinical specimens are vital for understanding assay performance and robustness. In our experience, this patient specimen-centered approach has required assay method modifications, some unexpected, but which were critical to successful implementation in clinical trials. In addition, dispersing assays throughout the National Cancer Institute's clinical trials network has required the development of calibrator and control materials as well as formal training courses for smooth implementation. One measure of success of this approach has been that a number of the assays developed at NCI's Frederick National Laboratory have ultimately reached the stage of commercialization, enabling wide accessibility of the PD biomarker assays by the research community.