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

描述（由申请人提供）：NCI-designated Dana-Farber/哈佛癌症中心（DF/HCC）包括Dana-Farber癌症研究所（DFCI）/布里格姆妇女医院（BWH）、马萨诸塞州综合医院（MGH）和贝斯以色列女执事医疗中心（BIDMC），负责监督在这些研究中心进行的临床试验的所有方面。DF/HCC作为牵头学术组织（LAO）申请UM 1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）计划自1993年以来一直在NCI/CTEP I期U 01协议的支持下协调DF/HCC的早期药物开发工作。在当前的资助期内（2008年2月1日至今），DF/HCC TPETT项目的成员参与了48项CTEP申办的试验，共招募了470例患者（85例/年）。DF/HCC还与其他U 01研究中心（如MSKCC、MDACC和Karmanos癌症研究所）合作开展CTEP试验。DF/HCC ET-CTN研究中心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、病理学、生物统计学和职业发展组成部分。DF/HCC将致力于与NCI和其他ET-CTN研究中心组建研究药物特定的跨网络项目团队，以确定药物开发计划并对CTEP申办的药物进行早期治疗试验。DF/HCC ET-CTN在药代动力学、药效学、癌症生物学、生物标志物检测开发、成像和分子表征方面的专业知识将以团队为基础的方法与其他研究中心共享。重点也将放在初级研究人员在实验治疗指导培训。

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.