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）一直是主要的临床与转化研究中心