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

项目总结-临床治疗单元（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为患者进行高质量的尖端临床研究。 提高对人类恶性肿瘤治疗的理解和进展。CTU/CTPL-SR 由两个不同但密切相关的单位组成，即临床治疗单位和临床 试验处理实验室（CTPL）。CCSG将只支持共享资源的CTPL组件; 反恐小组的支持将完全来自作战行动协调中心的机构资金，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采集和处理， 外部发送的样本，以及大多数将样本发送至OSUCCC的临床试验 研究者实验室或共享资源。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、处理和运输包括关于协议设计的咨询， 相关标本，按照方案规范采购和处理相关标本 制定方案在职材料，参与研究中心启动访视和方案实施 会议，协助监查访视和稽查，并将标本运送到OSU内部或外部， 分析. CTU/CTPL-SR与其他共享资源和部门协调， 当前临床试验所需的生物样本阵列。具体目标是：1）提供稳定的， 可靠的，具有成本效益的，最先进的单位进行早期临床试验，需要密集的 监测和/或复杂的相关标本采集;以及，2）提供高质量、高容量的标本 作为第一阶段相关组成部分收集的生物标本的处理、短期储存和分发， II和III转化临床试验。在目前的资助期内，CTU/CTP-SR已经支持了129个项目， 来自所有五个OSUCCC研究项目的研究人员（60%的OSUCCC成员）， 来自729项临床试验入组患者的104，831份标本。此外，反恐联盟/CTPL-SR为102个项目提供了捐助， 出版物（36> 10影响因子）。CTU/CTPL-SR将继续是一个重要的共享资源， 促进OSUCCC内的高质量转化研究，特别是考虑到目前的增长计划， 包括：a）免疫肿瘤学（Pelotonia免疫肿瘤学研究所）和翻译 基因组学;和B）承诺医学肿瘤学、血液学和妇科肿瘤学的招聘， 增加IND和试验应计费用的相应预期。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利用广泛的机构资源， 只有11.4%的人寻求CCSG基金的支持。

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.