Clinical Treatment Unit & Clinical Trials Processing Laboratory

临床治疗室

• 批准号: 8822218
• 负责人: Larry Joe Schaaf
• 金额: $ 18.8万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8822218
• 关键词: Area; Basic Science; Biological; Biological Markers; Biopsy; Blood; Blood specimen; Calibration; Cancer Center Support Grant; Cancer Hospital; Cancer Patient; Cells; Centrifugation; Clinic; Clinical; Clinical Nursing; Clinical Oncology; Clinical Research; Clinical Sciences; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Clinical assessments; Collection; Communities; Complex; Comprehensive Cancer Center; Correlative Study; Data; Development; Discipline of Nursing; Doctor of Philosophy; Documentation; Dose; Drug Kinetics; Electrocardiogram; Ensure; Faculty; Floor; Freezing; Funding; Future; Harvest; Human; Instruction; Laboratories; Laboratory Research; Leadership; Liquid substance; Location; Lymphoma; Malignant Neoplasms; Mission; Monitor; Mononuclear; National Cancer Institute; Nature; New Agents; Normal tissue morphology; Nurses; Ohio; Outcome; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Phase; Plasma; Play; Population Group; Prevention; Primary Neoplasm; Process; Protocols documentation; Publications; Quality Control; Regimen; Relative (related person); Research; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Role; Sampling; Serum; Skin; Solid Neoplasm; Specific qualifier value; Specimen; Specimen Handling; Swab; Target Populations; Telemetry; Temperature; Therapeutic Agents; Therapeutic Human Experimentation; Time; Toxic effect; Training; Translational Research; Universities; Venous; Visit; Wireless Technology; Work; biobank; cancer therapy; chemotherapy; cost effective; critical period; dosage; experience; improved; leukemia tissue bank; member; neoplastic cell; phase 1 study; phase I trial; phase II trial; programs; sample collection; translational clinical trial

The mission of the OSUCCC Clinical Treatment Unit and Clinical Trials Processing Laboratory Shared Resource (CTU/CTPL SR) is to advance the quality and efficiency of early phase clinical translational research. The CTU/CTPL SR is a new shared resource but has been in development since January 2004 when it was created to support and expand our ability to conduct early Phase I and II clinical trials. The CTU/CTPL SR is composed of two different but intimately related units: the Clinical Treatment Unit (CTU) and the Clinical Trials Processing Laboratory (CTPL). Historically, the CTU/CTPL SR has been funded solely with OSUCCC/institutional support. The CCSG will only support the CTPL component of the SR. The CTU is a $2 M ambulatory "phase 1 unit" constructed in The James Cancer Hospital in 2004. The CTU specializes in treating cancer patients on early clinical trials requiring intense monitoring and/or complex correlative specimen collection and processing. The CTPL enhances the quality of research by providing dedicated staff for high volume procurement, processing, storage, delivery, and shipment of research specimens critical to the correlative studies component of OSUCCC clinical trials. Highly trained staff in the CTU/CTPL SR works closely with the Clinical Trials Office (CTO), Pharmacoanalytical (PhASR), Leukemia Tissue Bank (LTBSR) and Biorepository and Biospecimen (BBR) Shared Resources to provide protocol review and feasibility assessment, specimen kit assembly and distribution of specimens to internal and external research laboratories. The infrastructure of the OSUCCC CTU/CTPL SR is well established and is directly under CCC leadership. Larry Schaaf, Ph.D., Director of the Resource brings a wealth of experience to the CTU/CTPL SR with over 20 years of experience in conducting and analyzing phase I clinical correlative trials and over 55 publications. The CTU/CTPL SR has been widely used by the OSUCCC clinical research community since its inception in 2004. During this time period, the CTU has supported 83 protocols involving >850 patients and more than 10,400 patient visits and the CTPL has procured and/or processed over 35,200 patient specimens. During the past year, 21 OSUCCC members have utilized the CTU/CTPL SR for 90 projects, representing 5 of the 6 OSUCCC programs and making up 80.3% of the overall CTU/CTPL SR usage, with the remainder being utilized by clinical oncology faculty who work directly with or for OSUCCC members. An additional 41 new protocols have been identified for future support In the first half of coming year. This Shared Resource will continue to enhance the quality of clinical translational research conducted at the OSUCCC by providing improved efficiency, enhanced compliance, and cost-effective centralized support of eerily phase correlative studies.

OSUCCC临床治疗单元和临床试验处理实验室共享的任务 资源（CTU/CTPL SR）是提高早期临床翻译的质量和效率 研究。 CTU/CTPL SR是一种新的共享资源，但自2004年1月以来一直在开发 创建它是为了支持和扩大我们进行早期第一阶段和II临床试验的能力。这 CTU/CTPL SR由两个不同但密切相关的单位组成：临床治疗单元（CTU） 以及临床试验处理实验室（CTPL）。从历史上看，CTU/CTPL SR已被资助 仅凭OSUCCC/机构支持。 CCSG仅支持SR的CTPL组件。 CTU是2004年在詹姆斯癌症医院建造的$ 2 m的卧床“ 1期单位”。 CTU专门针对早期临床试验治疗癌症患者，需要进行严格的监测和/或 复杂的相关标本收集和处理。 CTPL提高了研究质量 为高批量采购，加工，存储，交付和运输提供专用人员 研究标本对OSUCCC临床试验的相关研究成分至关重要。训练有素 CTU/CTPL SR的工作人员与临床试验办公室（CTO），药物分析（PHASR），PHASR）紧密合作。 白血病组织库（LTBSR）和生物座状和生物森林（BBR）共享资源 协议审查和可行性评估，标本套件组装以及标本分布到内部 和外部研究实验室。 OSUCCC CTU/CTPL SR的基础架构已建立得很好 直接在CCC领导下。资源总监拉里·沙夫（Larry Schaaf）博士带来了很多 在CTU/CTPL SR的经验中，具有超过20年的进行I阶段的经验 临床相关试验和超过55个出版物。 CTU/CTPL SR已被广泛使用 OSUCCC临床研究社区自2004年成立以来。在此期间，CTU拥有 支持83种涉及850名患者和10,400多名患者就诊的方案，CTPL具有 采购和/或处理超过35,200个患者标本。在过去的一年中，有21名OSUCCC成员 已将CTU/CTPL SR用于90个项目，代表6个OSUCCC计划中的5个 总体CTU/CTPL SR使用量的80.3％，其余的则由临床肿瘤学院使用 直接与OSUCCC成员合作的人。还确定了另外41个新协议 未来的支持下半年。这种共享资源将继续提高 通过提高效率，在OSUCCC进行的临床翻译研究提高了 合规性和成本效益的集中支持，对相关性研究。