Shared Resource 05: Clinical Treatment Unit/ Clinical Trials Processing Lab (CTU/CTPL-SR)

共享资源 05：临床治疗室/临床试验处理实验室 (CTU/CTPL-SR)

• 批准号: 10553337
• 负责人: GREGORY A OTTERSON
• 金额: $ 17.94万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-12 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553337
• 关键词: Abbreviations; Address; Air; Ambulatory Care; Appointment; Basic Science; Biological; Biomedical Research; Biometry; Brain; Budgets; Cancer Biology; Cancer Center; Cancer Center Support Grant; Cancer Control; Cancer Hospital; Chemoprevention; Chest; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Collection; Comparative Pathology; Complex; Comprehensive Cancer Center; Consultations; Dangerousness; Development; Disease; Drug Kinetics; Electronics; Floor; Flow Cytometry; Funding; Genomics; Grant; Growth; Gynecologic Oncology; Hematology; Hospitals; Human; Immunologic Monitoring; Immunooncology; Institution; International; Intervention; Intramural Research Program; Investigational Therapies; Laboratories; Location; Malignant Neoplasms; Medical Oncology; Microscopy; Mission; Molecular Carcinogenesis; Monitor; NCI Center for Cancer Research; Nutrient; Ohio; Pediatric Hospitals; Pharmaceutical Chemistry; Pharmacodynamics; Pharmacogenomics; Phase; Phytochemical; Play; Proteomics; Protocols documentation; Publications; Research; Research Institute; Research Personnel; Resource Sharing; Retirement; Role; Sampling; Services; Shipping; Site; Specific qualifier value; Specimen; Specimen Handling; Surveys; System; Translational Research; Transportation; United States Food and Drug Administration; Universities; Validation; Vertebral column; Visit; animal imaging; biomedical informatics; cancer therapy; clinical translation; cost effective; design; digital imaging; drug development; early phase clinical trial; expectation; first-in-human; improved; investigator-initiated trial; leukemia; leukemia tissue bank; malignant breast neoplasm; meetings; member; oncology service; participant enrollment; pathology imaging; programs; recruit; sample collection; translational clinical trial; translational genomics; translational therapeutics

PROJECT SUMMARY – CLINICAL TREATMENT UNIT (CTU) AND CLINICAL TRIALS PROCESSING LABORATORY (CTPL) SHARED RESOURCE (CTU/CTPL-SR) An important scientific mission of the OSUCCC is to conduct high quality, cutting edge clinical research for the improved understanding and advancement in treatments of human malignancies. The CTU/CTPL-SR is composed of two different, but intimately related units, namely the Clinical Treatment Unit (CTU) and the Clinical Trials Processing Laboratory (CTPL). The CCSG will only support the CTPL component of the shared resource; support of the CTU component will be entirely from OSUCCC institutional funding, as has been the case for the last two CCSG cycles. The CTU/STPL-SR manages all clinical trial biospecimen collection and processing for samples that are sent externally, and for most clinical trials where samples are being sent to OSUCCC investigator laboratories or shared resources. Key services, in support of all clinical trials needing biospecimen collection, processing and shipping for the CTU/CTPL-SR include consultation on protocol design with regard to correlative specimens, procurement and processing of correlative specimens per protocol specifications developing protocol in-service materials, participating in site initiation visits and protocol implementation meetings, assisting in monitoring visits and audits and shipping specimens internal or external to OSU for analysis. The CTU/CTPL-SR coordinates with other shared resources and departments to address the wide array of biological specimens required for current clinical trials. The Specific Aims are to: 1) provide a stable, reliable, and cost-effective, state-of-the art unit for conducting early phase clinical trials requiring intense monitoring and/or complex correlative specimen collection; and, 2) provide high-quality, high-volume specimen processing, short-term storage and distribution of biospecimens collected as correlative components of phase I, II and III translational clinical trials. During the current grant period, the CTU/CTP-SR has supported 129 investigators (60% OSUCCC members) from all five OSUCCC research programs, and procured a total of 104,831 specimens from patients enrolled in 729 clinical trials. Also, the CTU/CTPL-SR contributed to 102 publications (36 > 10 impact factor). The CTU/CTPL-SR will continue to be an essential shared resource to facilitate high-quality translational research within the OSUCCC, especially given the current growth plans that include: a) recruitment for both immuno-oncology (Pelotonia Institute of Immuno-Oncology) and translational genomics; and b) commitments to medical oncology, hematology and gynecologic oncology for recruitments and corresponding expectations for increased INDs and trial accruals. The annual budget of the CTU-CTPL-SR is $1,104,344, yet the CCSG request is $126,251. As such, the CTU/CTPL-SR leverages extensive institutional support and seeks only 11.4% support from CCSG funds.

项目摘要 – 临床治疗室 (CTU) 和临床试验处理 实验室 (CTPL) 共享资源 (CTU/CTPL-SR) OSUCCC 的一项重要科学使命是开展高质量、前沿的临床研究 增进对人类恶性肿瘤治疗的理解和进步。 CTU/CTPL-SR 是 由两个不同但密切相关的单位组成，即临床治疗单位（CTU）和临床 试验处理实验室 (CTPL)。 CCSG将仅支持共享资源的CTPL组件； CTU 部分的支持将完全来自 OSUCCC 机构资金，就像 最后两个 CCSG 周期。 CTU/STPL-SR 管理所有临床试验生物样本的收集和处理 外部发送的样本，以及大多数临床试验的样本发送到 OSUCCC 研究人员实验室或共享资源。关键服务，支持所有需要生物样本的临床试验 CTU/CTPL-SR 的收集、处理和运输包括有关协议设计的咨询 相关标本、按照协议规范采购和处理相关标本 制定协议使用材料，参与现场启动访问和协议实施 会议，协助监督访问和审计，并将标本运送到俄勒冈州立大学内部或外部 分析。 CTU/CTPL-SR 与其他共享资源和部门协调，解决广泛的问题 当前临床试验所需的一系列生物标本。具体目标是：1）提供稳定、 可靠、具有成本效益、最先进的设备，用于进行需要大量的早期临床试验 监测和/或复杂的相关标本采集； 2) 提供高质量、大容量的样本 作为第一阶段相关成分收集的生物样本的处理、短期储存和分发， II 和 III 转化临床试验。在当前拨款期内，CTU/CTP-SR 已支持 129 来自所有五个 OSUCCC 研究项目的研究人员（60% OSUCCC 成员），总共采购了 来自患者的 104,831 份样本参加了 729 项临床试验。此外，CTU/CTPL-SR 还为 102 出版物（36 > 10 影响因子）。 CTU/CTPL-SR 将继续成为重要的共享资源 促进 OSUCCC 内的高质量转化研究，特别是考虑到当前的增长计划 包括：a) 免疫肿瘤学（Pelotonia 免疫肿瘤学研究所）和转化学的招募 基因组学； b) 对肿瘤内科、血液学和妇科肿瘤学的招募和承诺 对 IND 和试验应计增加的相应预期。 CTU-CTPL-SR 的年度预算为 1,104,344 美元，而 CCSG 的要求是 126,251 美元。因此，CTU/CTPL-SR 利用广泛的机构 只寻求 CCSG 基金 11.4% 的支持。