Molecular Clinical Trians

在过去的40年里，SJCRH 保持了高生产力， 杰出的记录， 开发新的治疗方法， 儿童癌症（图1）。的 持续不断的成功 行为使努力成为可能 创新的早期临床试验 通过临床和实验室的合作， 癌症研究小组 中心从历史上看，这些临床试验 主要研究药物代谢动力学 性质、临床疗效和毒性 毒品，因为大多数被认为是 通过非特异性细胞毒性作用 机制等的最新进展 对癌症生物学的理解 导致了药物的发展 针对特定的分子 癌细胞，例如酪氨酸抑制剂 激酶。因此，在过去的5年里， 年的临床比例 在癌症患者中进行的试验 分子靶向检测中心 治疗增加到 50%和75%（图1）。正确评价这类新药的抗癌特性需要 评估患者组织内药物靶标的表达和活性以及药物靶向的测量， 药代动力学、功效和毒性。因此，为了确保SJCRH保持在抗癌的最前沿， 在药物开发方面，它建立了MCTC，提供： 临床试验中药物靶点表达和活性的测定;有效和适当收集的系统 和处理临床样本;用于药物靶点敏感性和特异性分析的专家实验室设施， 这些临床材料;并支持对所有数据的适当分析和解释， 这些化验。以这种方式，MCTC共享资源直接响应 国家癌症研究所（NCI）临床试验委员会（对临床试验项目审查的回应 Armitage委员会），以及癌症研究中心为I期和II期试验设计提供的模板第7节 NCI的治疗学评价项目（CTEP）。

Over the last 40 years SJCRH has maintained a highly-productive and distinguished record in the development of new treatments of childhood cancers (Figure 1). The continued success of this ongoing effort is made possible by the conduct of innovative early phase clinical trials by collaborating clinical and laboratory research groups within the Cancer Center. Historically, these clinical trials have focused on the pharmacokinetic properties, clinical efficacy and toxicity of drugs, since most were believed to act through non-specific cytotoxic mechanisms. Recent advances in understanding of the biology of cancer have led to the development of drugs that target specific molecules within cancer cells, e.g. inhibitors of tyrosine kinases. Therefore, over the last 5 years the proportion of the clinical trials conducted within the Cancer Center that test molecular targeted therapies has increased to between 50 and 75% (Figure 1). The proper evaluation of the anticancer properties of this new class of drugs requires assessment of the expression and activity of the drug target within patient tissues alongside measures of drug pharmacokinetics, efficacy and toxicity. Therefore, to ensure that SJCRH remains at the forefront of anticancer drug development it has established the MCTC that provides: expert advice on the incorporation of molecular assays of drug target expression and activity within clinical trials; systems for the efficient and proper collection and handling of clinical samples; expert laboratory facilities for sensitive and specific analysis of drug targets in these clinical materials; and support for the appropriate analysis and interpretation of all data generated by these assays. In this manner the MCTC Shared Resource responds directly to recommendations made by the National Cancer Institute's (NCI) Clinical Trials Committee (response to the Clinical Trials Program Review Armitage Committee), and to section 7 of templates provided for both Phase I and II trial design by the Cancer Therapeutics Evaluation Program (CTEP) at NCI.