Molecular Clinical Trials Core (MCTC) Share Resource

分子临床试验核心 (MCTC) 共享资源

• 批准号: 8738019
• 负责人: Richard James Gilbertson
• 金额: $ 0.08万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738019
• 关键词: Advisory Committees; Antineoplastic Agents; Archives; Biological Assay; Cancer Biology; Cancer Center; Cancer Center Support Grant; Cerebrospinal Fluid; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Communication; Conduct Clinical Trials; Consent; Consultations; Data; Databases; Development; Developmental Therapeutics Program; Discipline; Drug Kinetics; Drug Targeting; Drug toxicity; Electronic Mail; Enrollment; Ensure; Evaluation; Feedback; Freezing; Funding Agency; Generations; Glass; Hospitals; Institution; Intranet; Laboratory Research; Logistics; Maintenance; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Molecular; Molecular Analysis; Molecular Target; National Cancer Institute; Nursing Staff; Paper; Patients; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Phase; Phase I/II Trial; Physicians; Positioning Attribute; Preparation; Procedures; Process; Program Reviews; Property; Protocols documentation; Published Comment; Recommendation; Research; Research Activity; Research Design; Research Personnel; Resource Sharing; Resources; Sampling; Services; Site; Slide; Staging; System; Technology; Testing; Time; Tissues; Toxic effect; Tyrosine Kinase Inhibitor; Whole Blood; Work; Writing; cancer cell; clinical efficacy; clinical material; cytotoxic; data quality; design; drug development; innovation; laboratory facility; meetings; member; programs; response; sample collection; success; therapeutic evaluation; tumor; web page; web site; working group

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.

在过去的40年里，SJCRH在开发新的治疗方法方面保持了高产和卓越的记录。 儿童癌症（图1）。癌症中心内的临床和实验室研究小组合作进行创新的早期临床试验，使这一持续努力的持续成功成为可能。从历史上看，这些临床试验主要集中在药物的药代动力学特性、临床疗效和毒性，因为大多数药物被认为是通过非特异性细胞毒性机制起作用的。对癌症生物学的理解的最新进展已经导致靶向癌细胞内的特定分子的药物的开发，例如酪氨酸激酶的抑制剂。因此，在过去的5年中，在癌症中心进行的测试分子靶向治疗的临床试验的比例增加到 50%和75%（图1）。正确评价这类新药物的抗癌特性需要评估患者组织内药物靶点的表达和活性，以及药物药代动力学，疗效和毒性的测量。因此，为了确保SJCRH保持在抗癌药物开发的最前沿，它建立了MCTC，提供：在临床试验中纳入药物靶点表达和活性的分子测定的专家建议;有效和适当收集和处理临床样品的系统;用于这些临床材料中药物靶点的敏感性和特异性分析的专家实验室设施;并支持对这些测定产生的所有数据进行适当的分析和解释。以这种方式，MCTC共享资源直接响应国家癌症研究所（NCI）临床试验委员会提出的建议（响应临床试验计划审查阿米蒂奇委员会），以及NCI癌症治疗药物评价计划（CTEP）为I期和II期试验设计提供的模板第7节。