12 Clinical and Translational Research Center

12 临床与转化研究中心

• 批准号: 10466993
• 负责人: David S. Hong
• 金额: $ 33.64万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-08-28 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10466993
• 关键词: Accountability; Beds; Budgets; Cancer Center; Cancer Center Support Grant; Cell Culture Techniques; Cell Separation; Cell Therapy; Center for Translational Science Activities; Client satisfaction; Clinical; Clinical Investigator; Clinical Management; Clinical Research; Clinical Trials; Collection; Complement; Complex; Custom; Data; Development; Developmental Therapeutics Program; Discipline of Nursing; Doctor of Philosophy; Drug Evaluation; Drug Kinetics; Ensure; Environment; Equipment; Equipment and supply inventories; Faculty; Freezing; Funding; Goals; Grant; Infrastructure; Interdisciplinary Study; Journals; Knowledge; Laboratory Research; Leadership; Learning; Location; Malignant Neoplasms; Monitor; Nature; New Agents; Patient Monitoring; Patients; Peer Review; Pharmacology; Phase; Physicians; Publications; Research; Research Activity; Resources; Sampling; Scientist; Services; Ships; Site; Specimen Handling; Stem cell transplant; System; Testing; Time; Training; Training and Education; Translational Research; Venous blood sampling; base; cancer care; cancer cell; cancer therapy; early phase clinical trial; experience; first-in-human; innovation; member; new technology; novel; novel strategies; novel therapeutics; patient oriented; phase 2 study; programs; safe patient; sample collection; tool; translational research program; transplantation therapy; treatment center

PROJECT SUMMARY: CLINICAL AND TRANSLATIONAL RESEARCH CENTER (CTRC) The Clinical and Translational Research Center (CTRC) is the dedicated MD Anderson site for complex biologically-based new drug evaluation. With its 32-room nursing treatment center and adjacent full-function research laboratory, the CTRC is an ideal location to perform intensive clinical trials with a focus on first-in- human, phase I, and phase II studies requiring rigorous time points and pharmacologic testing. The CTRC provides a distinct resource for physician-scientists and clinical investigators to develop new agents for cancer treatment by offering coordination of multidisciplinary research, regulatory compliance, budget development, intensive and time-sensitive monitoring of patients, phlebotomy, and prompt and accurate specimen processing, storage, tracking, and shipment. The CTRC director, Filip Janku, MD, PhD; co-director, Daniel Karp, MD; clinical administrative director, Brenda Brown, MSN, RN, OCN, NEA-BC; and assistant director, Passion Lockett, DrPH, CCRC, provide leadership through planning, directing, and coordinating the integration of services and transfer of knowledge between the CTRC and the other CCSG cores. Current services include biospecimen collection and processing ranging from basic pharmacokinetic sampling to cell isolation and enumeration. Major equipment includes 15 centrifuges, a biosafety cabinet, 6 ultra-low freezers, a cell culture analyzer, and an AeroScout freezer monitoring system. Demand for services has increased by 98% since the previous grant cycle, and the CTRC has met this demand by increasing efficiency and increasing capacity by expanding from 18 beds to 32. Over the 6-year period, the CTRC facilitated 193 cancer center members who produced 184 publications, with 92 (50%) in journals with IF >5 and 38 (21%) in journals with IF >10, including N Engl J Med, Lancet, Nature, Nat Med, J Clin Oncol, and Cancer Cell. The CTRC's total operating budget in the current grant year (Yr43) is $5,050,892, and the CCSG accounts for 4% ($213,297). A total of ~$600,000 was provided for research equipment ($55,402) and renovations. In Yr42, 110 cancer center members used the CTRC, and 55% of all usage was by peer review-funded users. All CCSG programs used the CTRC, with 38% of all usage by the Developmental Therapeutics Program, followed by the Stem Cell Transplantation and Cellular Therapy Program (13%). In Yr44, 4% ($218,178) is requested from the CCSG. The CTRC Specific Aims are: Aim 1: To leverage the infrastructure and support for transformative high-impact early-phase clinical trials; Aim 2: To develop, customize and implement a new clinical trials management system to increase efficiency, accountability, transparency, plus data and sample integrity; Aim 3: To implement tools to evaluate patients' satisfaction and deliver patient-centered clinical research; and Aim 4: To provide expertise, training and education to research staff, faculty, and trainees.

项目摘要：临床和转化研究中心（CTRC） 临床和转化研究中心（CTRC）是复杂的专用MD Anderson网站 基于生物学的新药评估。拥有32个房间的护理治疗中心和相邻的全功能 研究实验室，CTRC是进行强化临床试验的理想场所，重点是 人，第一阶段和第二阶段研究需要严格的时间点和药理测试。 CTRC 为医师科学家和临床研究人员提供了一个独特的资源，以开发新的癌症药物 通过提供多学科研究，监管合规性，预算制定的协调来治疗 对患者的密集和时间敏感监测，静脉切开术以及迅速而准确的标本处理， 存储，跟踪和装运。 CTRC主任，医学博士Filip Janku；联合导演，丹尼尔·卡普（Daniel Karp），医学博士； 临床行政总监，Brenda Brown，MSN，RN，OCN，NEA-BC；和助理导演，洛克·洛克特 DRPH，CCRC，通过计划，指导和协调服务的整合以及 CTRC与其他CCSG核之间的知识转移。当前的服务包括生物测试 收集和加工范围从基本的药代动力学采样到细胞分离和枚举。主要的 设备包括15个离心机，一个生物安全柜，6个超低冷冻机，一个细胞培养分析仪和一个 Aeroscout冷冻监控系统。自上一个赠款周期以来，对服务的需求增长了98％， CTRC通过从18张床扩展来提高效率和增加能力来满足这一需求 到32岁。在6年期间，CTRC促进了193个癌症中心成员，他们生产了184个出版物， 在期刊中，有92（50％）的期刊中的期刊（21％）在IF> 10的期刊中，包括N Engl J Med，Lancet，Nature，Nature， Nat Med，J Clin Oncol和癌细胞。 CTRC在当前赠款年度（YR43）的总运营预算是 $ 5,050,892，CCSG占4％（$ 213,297）。总共提供了约60万美元的研究 设备（55,402美元）和翻新。在YR42中，110个癌症中心成员使用了CTRC，其中55％ 用法是由同行评审资助的用户使用的。所有CCSG程序都使用CTRC，其中38％的使用量 发育治疗计划，然后进行干细胞移植和细胞治疗计划 （13％）。在YR44中，CCSG要求提供4％（$ 218,178）。 CTRC具体目的是：目标1：利用 基础设施和对变革性高影响力早期临床试验的支持；目标2：发展， 自定义和实施新的临床试验管理系统，以提高效率，问责制， 透明度，数据和样本完整性；目标3：实施工具来评估患者的满意度和 提供以患者为中心的临床研究；目标4：为研究提供专业知识，培训和教育 员工，教职员工。