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，临床和转化研究中心（CTRC）一直是主要的 以患者为导向，以协议为基础，创新的临床和转化研究的网站。关键阶段一和二 自2002年以来，这些研究已经促成了18种新的FDA批准的癌症药物的开发。最高 优先考虑那些试图回答以生物学为基础的研究问题的研究。NIH同行评审 自2002年以来，研究包括>15%的CTRC活动和> 37%的患者登记。总 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，本提案仅要求实验室预算的14%（25.4万美元）。的 CTRC提供出色的护理，全面的静脉切开术/药代动力学（PK）实验室服务， 药效学（PD）研究，以及严格的研究基础设施和监督。核心补助金 资金的杠杆比例超过2：1，以支持否则无法进行的相关研究。在 过去5年，在450多个方案中记录了7，750例患者登记，代表96 来自16个项目的研究人员。仅在2007年，就有15，099例患者就诊，> 12，000例PK/PD 时间点。CTRC使用广泛的靶向小分子、免疫剂、信号转导和免疫抑制剂。 转导抑制剂、表观遗传调节剂、疫苗和蛋白体抑制剂。经典细胞毒性药物 不到所有药物研究的1/3。该单位在2003年获得了高度好评， 明确建议加强收费服务的收费。从那时起，我们 建立了一个强大的会计和计费系统，现在贡献了超过50万美元（28%）的总额 预算一名医疗主任和护士长监督日常活动， 委员会指导研究的发展和优先次序。最近招聘的博士实验室经理 将监督我们日益复杂的第一阶段研究新服务包括： 冷冻标本的编目系统;蛋白质组学、DMA、RNA分析和 单核细胞分离;样本运输的实时主要研究者电子邮件通知; 24小时 静脉切开术覆盖范围;以及用于方案特异性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%的年增长率; 开发一个全面的网上甲骨文应用程序，以取代纸张和手写系统。 2007年2月，研究中心获得150万美元的捐赠，用于开发一个计算机化的高级研究中心。 管理和数据分析系统（阿尔马达项目），进一步利用NIH的 投资所要求的资金将用于支持执行所需的关键静脉切开术和实验室服务， 当今高度复杂的转译抗癌药物开发。