Biomarker Investigations for Clinical Trials

分子靶点核心（MTC，需要讨论）提供全面的生物标志物分析，是肿瘤学临床试验的组成部分和关键部分。Core在高灵敏度、非常特异性和极其准确的研究性生物标志物测量方面具有卓越的能力，其中大多数生物标志物无法在常规临床诊断实验室中测量或检测。临床标本中这些生物标志物的定量测定提供了必要的信息，以证明实验药物在抑制其预期靶点方面的有效性，并在临床试验的早期阶段在患者中实现其生物学效应。在与临床反应相关的研究中，一些生物标志物也可以提供对那些可能预测患者对新型或新型药物的反应的见解。MTC作为负责生物标志物研究的共同研究者参与临床试验。它在设计、开发和实施用于新型肿瘤药物试验的生物标志物研究方面拥有丰富的经验。核心目前支持NCI的近40项临床试验。它在临床研究的生物标志物分析方面具有深入的经验。MTC还可以为NCI的所有研究人员提供高灵敏度和多重检测细胞内蛋白质，细胞因子，生长因子和许多其他生物标志物，以合作方式或以显着低于市场的费用。Core能够在肿瘤学、免疫学、心血管和中枢神经系统等领域进行生物标志物检测。除了人体研究外，Core还能够在临床前动物模型（包括小鼠和大鼠）中进行生物标志物分析。因此，核心在涵盖广泛学科的临床和临床前生物标志物研究方面拥有卓越的专业知识。MTC在开发新生物标志物的高质量检测方面也是独一无二的，并将帮助所有研究人员开发用于临床研究的高灵敏度检测。这种能力使研究人员能够以可承受的价格开发和定制用于体内生物标志物研究的高质量测定。

The Molecular Targets Core (MTC, needs discussion) provides comprehensive biomarker analyses that are integral and critical parts of oncology clinical trials. The Core has exceptional capabilities in high sensitive, very specific, and extremely accurate measurements of investigational biomarkers with most of them cannot be measured or detected in a regular clinical diagnostic lab. The quantitative determination of these biomarkers in clinical specimens provides essential information to demonstrate the effectiveness of the experimental agents in inhibiting their intended targets and in achieving their biological effects in the patients in early phases of clinical trials. In correlative studies with clinical responses, some of the biomarkers may also provide an insight into those that may be predictive of the response in patients on novel or new agents. MTC engages clinical trials as co-investigators responsible for biomarker investigations. It has extensive experiences in designing, developing and implementing biomarker investigations for trials of novel oncology agents. The Core currently supports nearly 40 clinical trials at NCI. It has an in-depth experience in biomarker analysis for clinical studies. MTC can also provide highly sensitive and multiplex testing for intracellular proteins, cytokines, growth factors, and many other biomarkers for all investigators at NCI in collaborative ways or for a fee which is significantly lower than that in the market. The Core is capable of performing biomarker assays in areas including oncology, immunology, and cardiovascular and central nervous systems. In addition to human studies, the Core is further capable of performing biomarker analysis in preclinical animal models including mouse and rat. Thus, the Core has exceptional expertise in both clinical and preclinical biomarker studies covering a wide-range of disciplines. MTC is further unique in developing very high quality assays for new biomarkers and will assist all investigators to develop highly sensitivity assays for clinical studies. This capability allows investigators to develop and customize high quality assays for in vivo biomarker studies at affordable prices.