Clinical and Translational

自1990年成立以来，临床与翻译研究中心(CTRC)一直是 面向患者、基于方案、创新的临床和转译研究网站。关键阶段I和II 自2002年以来，研究为FDA批准的18种抗癌新药的开发做出了贡献。最高值 优先考虑寻求回答基于生物学的研究问题的研究。美国国立卫生研究院同行评审 自2002年以来，研究已经包括了CTRC活动的15%和患者登记的37%。总数 CTRC的年度预算增加到350万美元(20.5个临床FTE和33.6个实验室FTE)。实验室 预算为180万美元，在这项提案中只要求实验室预算的14%(254K美元)。这个 CTRC为药代动力学(PK)提供出色的护理、全面的静脉采血/实验室服务和 药效学(PD)研究，以及严格的研究基础设施和监督。核心赠款 资金的杠杆比例超过2：1，用于支持以其他方式无法进行的相关研究。在……里面 在过去的5年中，有超过450种方案记录了7,750例患者登记，相当于96 来自16个项目的调查人员。仅在2007年，就有15,099次病人就诊和12,000 PK/PD 时间点。CTRC使用广泛的靶向小分子、免疫剂、Signal 转导抑制剂、表观遗传调节剂、疫苗和蛋白酶体抑制剂。经典细胞毒剂 占所有药物研究的不到三分之一。该单位在2003年获得高度好评， 明确建议加强收费服务的收费捕获。从那时起，我们已经 建立了强大的会计和账单系统，目前贡献了超过500,000美元(28%) 预算。一名医务主任和护士经理监督日常活动，并由20名成员监督 委员会指导研究的发展和优先顺序。一位新近招聘的博士实验室经理 将为我们日益复杂的第一阶段研究提供监督。新服务包括：计算机化 冷冻标本的编目系统；蛋白质组学、DNA、RNA分析和 单核细胞分离；样品运输的实时首席调查员电子邮件通知；24小时 静脉采血覆盖范围；以及针对特定协议的PK和PD套件的安全“即时”库存系统。 未来的计划包括：将实验室事务处重组为4个小组，以改善与 个人癌症中心计划，并扩大实验室空间，以适应30%的年增长； 开发一个全面的基于Web的Oracle应用程序，以取代纸质和手写系统。 2007年2月，CTRC吸引了150万美元的捐款，用于开发计算机化的高级研究 管理和数据分析系统(ARMADA项目)，进一步利用NIH的价值 投资。申请的资金将用于支持关键的静脉抽液和实验室服务 当今高度复杂的转化型抗癌药物的开发。

Since its inception in 1990, the Clinical & Translational Research Center (CTRC) has served as the primary site for patient-oriented, protocol-based, innovative clinical and translational research. Key phase I and II studies have contributed to the development of 18 new FDA-approved cancer drugs since 2002. Highest priority is given to studies that seek to answer biologically-based research questions. NIH peer-reviewed studies have comprised >15% of CTRC activity and > 37% of patient registrations since 2002. The total CTRC annual budget has increased to $3.5 million (20.5 clinical FTEs and 33.6 lab FTEs). The laboratory budget is $1.8M of this total, and only 14% ($254K) of the lab budget is requested in this proposal. The CTRC provides outstanding nursing care, full phlebotomy/lab services for pharmacokinetic (PK) and pharmacodynamic (PD) studies, as well as rigorous research infrastructure and oversight. Core grant funding is leveraged more than 2:1 to support correlative studies that could not be conducted otherwise. In the last 5 years, 7,750 patient registrations recorded on over 450 protocols, representing usage by 96 investigators from 16 programs. In 2007 alone, there have been 15,099 patient visits and >12,000 PK/PD timepoints. The CTRC uses a broad array of targeted small molecules, immunologic agents, signal transduction inhibitors, epigenetic modulators, vaccines, and proteosome inhibitors. Classic cytotoxic agents comprise less than 1/3 of all drug studies. The unit received a highly-favorable review in 2003 with the explicit recommendation to strengthen charge capture for billable services. Since that time, we have instituted a robust accounting and billing system that now contributes over $500,000 (28%) to the total budget. A medical director and nurse manager supervise daily activities and a 20-member oversight committee directs development and prioritization of studies. A recently-recruited PhD Laboratory Manager will provide oversight of our increasingly-complex phase I studies. New services include: a computerized cataloging system for frozen specimens; specialized preparation for proteomics, DMA, RNA analysis, and mononuclear cell fractionation; real-time Principal Investigator email notification of sample shipments; 24-hr phlebotomy coverage; and a secure "just-in-time" inventory system for protocol-specific PK and PD kits. Future plans include: re-organization of the Lab Service into 4 teams to improve communication with the individual Cancer Center programs, and expansion of lab space to accommodate 30% annual growth; development of a comprehensive web-based Oracle application to replace paper and handwritten systems. In February 2007, the CTRC attracted a $1.5M gift to develop a computerized Advanced Research Management and Data Analysis system (the ARMADA project), leveraging further the value of NIH's investment. Funds requested will support the critical phlebotomy and laboratory services needed to execute today's highly-complex translational cancer drug development.