EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-017)

核心017：早期临床研究支持 项目总结/摘要 早期临床研究支持（EPCRS）的总体目标是促进和维持创新 由范德比尔特-英格拉姆癌症中心（VICC）成员进行的新疗法或设备的临床研究。 VICC研究者为了解肿瘤形成、癌基因和肿瘤的驱动因素做出了重大贡献。 成瘾、新生和获得性耐药性以及药物作用的预测性生物标志物。EPCRS基金有 在执行几项以这些主题为重点的创新审判时，这是必不可少的。十二名调查员- 启动试验（IIT）在上一个资助期内得到了EPCRS的支持。这些已经产生了 额外的赠款支持和出版物，以及导致更大的后期临床试验。 维也纳国际中心于2007年设立的资源分配委员会负责管理 CCSG和VICC机构基金根据科学价值和优先事项向IIT提供EPCRS资金。 中心这是由来自多个癌症学科的教师组成的委员会审查后完成的 在VICC中有代表，包括内科、外科、放射和儿科肿瘤学、癌症基因组学， 转化研究，非侵入性成像用于确定EPCRS资金分配的标准主要是 包括：来自VICC成员的支持性临床前数据，可能导致更大的多机构关键研究 II/III期试验和校外资助，可行性，原创性，新型分子和成像相关物，以及 为初级调查员提供指导。医疗主任密切监测赠款的管理情况 临床试验共享资源（CTSR）、RAC主席、财务办公室和人力资源， 每季度评估一次。维也纳国际中心的若干举措和机构间互动支持建立一个良好的 当前和期间可能符合EPCRS支持条件的临床试验生成环境 下一个融资期。其中包括靶向治疗中心（C2T2），创新的转化 研究（ITR）共享资源，下一代测序（NGS）工作组，范德比尔特 癌症成像支持实验室（CISL）、范德比尔特大学成像科学研究所（VUIIS）和 范德比尔特化学生物学研究所。C2T2主持和协调分子肿瘤委员会， 客座教授（ViP）系列研讨会、C2T2-Pharma座谈会和C2T2工作室，所有这些都代表了 寻求EPCRS支持的应用程序来源。这些资金还支持早期试验， 国家临床试验网络（NCTN）内的大型试验，其中VICC被授予领先的学术 参与研究中心（LAPS）补助金。在上一个供资期间，EPCRS继续支持VICC 研究人员利用他们在精准医学和早期药物开发方面的专业知识。

CORE 017: EARLY PHASE CLINICAL RESEARCH SUPPORT PROJECT SUMMARY/ABSTRACT The overall goal of Early Phase Clinical Research Support (EPCRS) is to catalyze and sustain innovative clinical studies of novel therapies or devices conducted by Vanderbilt-Ingram Cancer Center (VICC) members. VICC investigators have contributed significantly to the understanding of drivers of neoplasia, oncogene addiction, de novo and acquired drug resistance and predictive biomarkers of drug action. EPCRS funds have been essential to the execution of several innovative trials focused on these themes. Twelve investigator- initiated trials (IITs) have been supported by EPCRS during the last funding period. These have generated additional grant support and publications as well as led to larger late phase clinical trials. The Resource Allocation Committee (RAC), created by VICC in 2007, manages the distribution of EPCRS funds from the CCSG and VICC institutional funds to IITs based on scientific merit and priorities of the Center. This is done following review by a committee composed of faculty from multiple cancer disciplines represented in VICC including medical, surgical, radiation and pediatric oncology, cancer genomics, translational research, non-invasive imaging. Criteria used to determine allocation of EPCRS funds mainly include: supportive preclinical data from VICC members, potential to lead to larger multi-institutional pivotal phase II/III trials and extramural funding, feasibility, originality, novel molecular and imaging correlatives, and mentorship for junior investigators. Management of awarded funds is closely monitored by the Medical Director of the Clinical Trials Shared Resource (CTSR), RAC Chairperson, Finance Office, and Human Resources and evaluated on a quarterly basis. Several VICC initiatives and institutional interactions support an excellent environment for the generation of clinical trials potentially eligible for EPCRS support currently and during the next funding period. These include the Center for Targeted Therapies (C2T2), the Innovative Translational Research (ITR) Shared Resource, the Next Generation Sequencing (NGS) Working Group, the Vanderbilt Cancer Imaging Support Laboratory (CISL), the Vanderbilt University Institute of Imaging Sciences (VUIIS) and the Vanderbilt Institute of Chemical Biology (VICB). The C2T2 hosts and coordinates Molecular Tumor Boards, a Visiting Professor (ViP) seminar series, C2T2-Pharma Colloquia, and C2T2 Studios, all representing a source of applications seeking support by EPCRS. These funds also support early phase trials that can lead to larger trials within the National Clinical Trials Network (NCTN), where VICC was awarded a Lead Academic Participating Site (LAPS) grant. During the last funding period, EPCRS has continued to support VICC investigators in the use of their expertise in precision medicine and early drug development.