Early Phase Clinical Research Support

早期临床研究支持（EPCRS） 摘要 新墨西哥州大学癌症中心（UNMCC）的早期临床研究支持（EPCRS）， 由医学博士Olivier Rixe领导，支持开发和进行早期阶段的加速器启动 试验（IIT）。该委员会的目标是加快赔偿委员会成员的发现速度， 转化为设计和实施创新的早期阶段药物启动试验， 所有新墨西哥人。这一目标得到了四个国家以癌症为重点的前沿研究的支持 UNCC研究项目，特别是在癌症治疗方面开发的转化管道： 技术、发现和靶向治疗（CT）计划以及联合国儿童基金会临床研究基础设施 包括临床试验办公室、共享资源和新墨西哥州癌症护理联盟 （NMCCA），一个基于UNMCC的全州癌症临床试验网络。在本供资期间， 使用癌症中心支持补助金（CCSG）发展基金与其他基金相结合 联合国赔偿委员会的资源，以补充咨询小组支助的早期临床研究支助（以前称为 方案特定研究支持（PSRS）），为以下项目提供临床研究基础设施和资金 由联合国儿童基金会成员设计的早期临床试验的相关实验室研究。以来 2010年，10项0期和1期研究得到了联合国赔偿委员会的支持。2013年，28例患者入组 3项试点I期机构临床试验。这些初步调查都是根据联合国赔偿委员会成员的研究结果提出的 并涉及来自多个途径的不同蛋白质靶点（GTP酶，DNA修复蛋白，整合素）， 多种癌症（卵巢癌、白血病、卵巢癌、头颈部鳞状细胞癌等 实体瘤）。根据联合国赔偿委员会外部咨询委员会的指导， 已实施该项目，以加强联合国儿童基金会的早期临床研究。Olivier Rixe，医学博士，博士，专家 在早期临床试验和药物开发中，被聘为临床研究副主任， 2014年7月1日加入UNCC。还对联合国赔偿委员会第一阶段单位的基础设施进行了重组 并加以扩大，以加强EPCRS组成部分的影响。已经建立了一些程序， 联合国儿童基金会临床工作组和联合国儿童基金会四个研究项目之间的直接合作 重点是根据以下研究结果为早期临床试验开发新概念： 赔偿委员会成员。这些概念将使用一个独特的优先级系统进行评价，该系统涉及临床 工作组和议定书审查和监测委员会。联合国赔偿委员会已承付50万美元 除了请求的CCSG资金外，每年从其他资金来源为EPCRS提供资金，目标是 在联合国赔偿委员会内增加新的和创新的早期阶段由赔偿委员会发起的研究的比例 临床试验组合。目前正在研究超过27个概念，以进行进一步的临床开发。

EARLY PHASE CLINICAL RESEARCH SUPPORT (EPCRS) ABSTRACT Early Phase Clinical Research Support (EPCRS) at the University of New Mexico Cancer Center (UNMCC), led by Olivier Rixe, MD, PhD, supports the development and the conduct of early phase investigator-initiated trials (IITs). The goal of ECPRS is to increase the pace at which discoveries by UNMCC members are translated into the design and conduct of innovative early phase investigator-initiated trials that are accessible to all New Mexicans. This objective is supported by the cutting-edge, cancer-focused research in the four UNMCC Research Programs, in particular the translational pipeline developed in the Cancer Therapeutics: Technology, Discovery, and Targeted Delivery (CT) Program, and the UNMCC clinical research infrastructure that includes the Clinical Trials Office, Shared Resources and the New Mexico Cancer Care Alliance (NMCCA), a UNMCC-based statewide cancer clinical trials network. In the current funding period, the UNMCC used Cancer Center Support Grant (CCSG) Developmental Funds in combination with funds from other UNMCC sources to supplement CCSG-supported Early Phase Clinical Research Support (formerly known as Protocol Specific Research Support (PSRS)) to provide the clinical research infrastructure and funding for associated-laboratory studies for early phase clinical trials that were designed by UNMCC members. Since 2010, 10 Phase 0 and Phase I studies have been supported by UNMCC. In 2013, 28 patients were enrolled on 3 pilot Phase I institutional clinical trials. These IITs all resulted from research findings by UNMCC members and involved different protein targets from multiple pathways (GTPases, DNA repair proteins, integrins) in a large variety of cancers (ovary, leukemia, ovarian cancer, head and neck squamous cell carcinoma and other solid tumors). Following guidance from the UNMCC External Advisory Committee, several major changes have been implemented to enhance early phase clinical research at the UNMCC. Olivier Rixe, MD, PhD, an expert in early phase clinical trials and drug development, was recruited as Associate Director for Clinical Research, joining the UNMCC on July 1, 2014. The infrastructure for the UNMCC Phase I unit has also been reorganized and expanded to enhance the impact of the EPCRS component. Processes have been established to stimulate direct collaborations between the UNMCC Clinical Working Groups and the four UNMCC Research Programs that focus on the development of novel concepts for early phase clinical trials based on research findings by UNMCC members. These concepts will be evaluated using a unique prioritization system involving the Clinical Working Groups and the Protocol Review and Monitoring Committee. The UNMCC has committed $500,000 per year from other funding sources in addition to the requested CCSG funds for EPCRS, with the goal of increasing the proportion of novel and innovative early phase investigator-initiated studies within the UNMCC clinical trial portfolio. More than 27 concepts are currently being investigated for further clinical development.