Clinical and Translational

临床和转化

• 批准号: 7695952
• 负责人: DANIEL D KARP
• 金额: $ 21.42万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-28 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7695952
• 关键词: Accounting; Administrator; Adoption; Adverse Drug Experience Report; Adverse Drug Reaction Reporting Systems; Antineoplastic Agents; Area; Award; Budgets; Cancer Center; Cancer Center Support Grant; Care given by nurses; Cataloging; Catalogs; Cell Fractionation; Charge; Clinic; Clinical; Clinical Medicine; Clinical Research; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Communication; Complement; Complex; Correlative Study; Cytotoxic agent; Daily; Data Analyses; Databases; Development; Doctor of Philosophy; Drug Kinetics; Electronic Mail; Epigenetic Process; Equipment and supply inventories; Fees; Foundations; Freezing; Funding; Future; Gifts; Grant; Growth; Handwriting; Health Sciences; Hospitals; Immunologics; Individual; Infusion Pumps; Infusion procedures; Institutes; Institution; Intranet; Investments; Just-in-time-concept; Laboratories; Malignant Neoplasms; Medical; Medical Records; Medicine; Metabolic; Mononuclear; Notification; Nurse Administrator; Nursing Services; Online Systems; Outpatients; Paper; Pathology; Patients; Peer Review; Pharmaceutical Preparations; Pharmacodynamics; Pharmacy facility; Phase; Phase I Clinical Trials; Physician Executives; Play; Policies; Positioning Attribute; Preparation; Principal Investigator; Process; Proteomics; Protocols documentation; RNA analysis; Recommendation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Research Project Grants; Residual state; Resource Sharing; Role; Sampling; Secure; Services; Signal Transduction Inhibitor; Site; Source; Specialist; Specimen; System; Systems Analysis; Time; Today; Translational Research; Treatment Protocols; United States National Institutes of Health; University of Texas M D Anderson Cancer Center; Update; Urine; Vaccines; Venous blood sampling; Virginia; Visit; anticancer research; austin; base; cancer prevention; computerized; cost; data management; density; digital; drug development; foot; improved; inhibitor/antagonist; innovation; member; multicatalytic endopeptidase complex; patient oriented; programs; small molecule; treatment center

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.

自 1990 年成立以来，临床与转化研究中心 (CTRC) 一直是该中心的主要机构。 面向患者、基于方案、创新的临床和转化研究的网站。关键一期和二期 自 2002 年以来，这些研究已促成 18 种 FDA 批准的新抗癌药物的开发。 优先考虑寻求回答基于生物学的研究问题的研究。 NIH 同行评审 自 2002 年以来，研究已涵盖 > 15% 的 CTRC 活动和 > 37% 的患者注册。 CTRC 年度预算已增加至 350 万美元（20.5 名临床 FTE 和 33.6 名实验室 FTE）。实验室 其中预算为 180 万美元，本提案仅要求实验室预算的 14%（25.4 万美元）。这 CTRC 提供出色的护理服务、全面的放血/实验室服务，用于药代动力学 (PK) 和 药效（PD）研究，以及严格的研究基础设施和监督。核心补助金 资金杠杆比例超过 2:1，用于支持否则无法进行的相关研究。在 过去 5 年，超过 450 个协议记录了 7,750 名患者注册，代表使用量为 96 来自 16 个项目的研究人员。仅 2007 年一年，就诊患者 15,099 人次，PK/PD 超过 12,000 次 时间点。 CTRC 使用广泛的靶向小分子、免疫制剂、信号 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 1/3。该单位在 2003 年获得了高度好评 明确建议加强计费服务的收费捕获。从那时起，我们就有了 建立了强大的会计和计费系统，目前贡献总额超过 500,000 美元 (28%) 预算。一名医务主任和一名护士经理负责监督日常活动，并由 20 名成员负责监督 委员会指导研究的发展和优先顺序。最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： 冷冻标本编目系统；蛋白质组学、DMA、RNA 分析的专门准备 单核细胞分级分离；首席研究员实时发送样品发货电子邮件通知； 24小时 静脉放血覆盖范围；以及针对特定方案 PK 和 PD 试剂盒的安全“及时”库存系统。 未来的计划包括： 将实验室服务重组为 4 个团队，以改善与实验室的沟通 单独的癌症中心项目，以及扩大实验室空间以适应每年 30% 的增长； 开发基于 Web 的综合 Oracle 应用程序以取代纸质和手写系统。 2007 年 2 月，CTRC 获得了 150 万美元的捐赠，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。请求的资金将支持执行所需的关键静脉切开术和实验室服务 当今高度复杂的转化癌症药物开发。