Dana-Farber/Harvard Cancer Center ET-CTN with Phase I Emphasis

描述（由申请人提供）：nci指定的丹娜-法伯/哈佛癌症中心（DF/HCC）。包括丹娜-法伯癌症研究所(DFCI)/布里格姆妇女医院（BWH），马萨诸塞州总医院（MGH）和贝斯以色列女执事医疗中心（BIDMC），并负责监督在这些地点进行的临床试验的各个方面。作为牵头学术组织（LAO）的DF/HCC申请UM1合作协议的总体目标是提供临床和科学专业知识以及患者资源，以参与整合的NCI实验治疗-临床试验网络（ET-CTN）。DF/HCC转化药理学和早期治疗试验（TPETT）项目协调了DF/HCC的早期药物开发工作。NCI/CTEP I期U01协议自1993年起生效。在目前的资助期内（2008年2月1日至今），DF/HCC TPETT项目的成员已经参与了48项ctep资助的试验，总计470例患者（85例/年）。DF/HCC还与其他U01研究中心（如MSKCC、MDACC和Karmanos Cancer Institute）合作进行CTEP试验。DF/HCC ET-CTN网站将由一个领导和指导委员会组成，该委员会将监督监管、药代动力学、基因组学、病理基础、生物统计学和职业发展等组成部分。DF/HCC将致力于与NCI和其他ET-CTN站点组成研究性特定药物的跨网络项目团队，以确定药物开发计划并进行ctep资助的药物的早期治疗试验。DF/HCC ET-CTN在药代动力学、药效学、癌症生物学、生物标志物分析开发、成像和分子表征方面的专业知识将以团队为基础的方式与其他站点共享。重点也将放在指导培训初级研究人员在实验治疗。

DESCRIPTION (provided by applicant): The NCI-designated Dana-Farber/Harvard Cancer Center (DF/HCC).includes the Dana-Farber Cancer Institute (DFCI)/Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and the Beth Israel Deaconess Medical Center (BIDMC) and functions in overseeing all aspects of clinical trials performed at these sites. The overall objective of this UM1 Cooperative Agreement application from the DF/HCC, which serves as the Lead Academic Organization (LAO), is to provide the clinical and scientific expertise and patient resources to participate in the integrated NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN). The DF/HCC Translational Pharmacology and Early Therapeutic Trials (TPETT) Program has coordinated early phase drug development efforts at DF/HCC with support under an.NCI/CTEP Phase I U01 Agreement in place since 1993. During the current funding period (2/1/2008-present), members of the DF/HCC TPETT Program have participated in the conduct of 48 CTEP-sponsored trials with an overall accrual of 470 patients (85/year). The DF/HCC has also collaborated with other U01 sites, such as MSKCC, MDACC and Karmanos Cancer Institute, in the performance of CTEP trials. The DF/HCC ET-CTN site will consist of a Leadership and Steering Committee that will oversee regulatory, pharmacokinetic, genomic, pathology-based, biostatistical, and career development components. DF/HCC will be committed to the formation of investigational agent-specific trans-network Project Teams with the NCI and other ET-CTN sites to define drug development plans and conduct early phase therapeutic trials of CTEP-sponsored agents. Expertise of the DF/HCC ET-CTN in pharmacokinetics, pharmacodynamics, cancer biology, biomarker assay development, imaging and molecular characterizations will be shared with other sites in team-based approaches. Emphasis will also be placed on mentored training of junior investigators in experimental therapeutics.