Clinical Treatment Unit and Clinical Trials Processing Laboratory Shared Resource

临床治疗单位和临床试验处理实验室共享资源

• 批准号: 9221249
• 负责人: Larry Joe Schaaf
• 金额: $ 13.79万
• 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/9221249
• 关键词: Abbreviations; Accounting; Cancer Center Support Grant; Cancer Control Research Program; Cancer Hospital; Chemoprevention; Clinical; Clinical Oncology; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Collection; Complex; Contracts; Correlative Study; Faculty; Funding; Grant; Grouping; Institution; Investments; Laboratories; Laboratory Research; Mission; Molecular Biology; Molecular Carcinogenesis; Monitor; Names; Outpatients; Patients; Phase; Process; Protocols documentation; Publications; Research; Resource Sharing; Ships; Specimen; Specimen Handling; Supervision; Therapeutic; Therapeutic Clinical Trial; Time; Training; Translational Research; Visit; Work; cancer clinical trial; cancer genetics; clinical research site; cost effective; high risk; improved; laboratory experiment; leukemia; man; member; programs; sample collection; translational clinical trial; Abbreviations; Accounting; Cancer Center Support Grant; Cancer Control Research Program; Cancer Hospital; Chemoprevention; Clinical; Clinical Oncology; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Collection; Complex; Contracts; Correlative Study; Faculty; Funding; Grant; Grouping; Institution; Investments; Laboratories; Laboratory Research; Mission; Molecular Biology; Molecular Carcinogenesis; Monitor; Names; Outpatients; Patients; Phase; Process; Protocols documentation; Publications; Research; Resource Sharing; Ships; Specimen; Specimen Handling; Supervision; Therapeutic; Therapeutic Clinical Trial; Time; Training; Translational Research; Visit; Work; cancer clinical trial; cancer genetics; clinical research site; cost effective; high risk; improved; laboratory experiment; leukemia; man; member; programs; sample collection; translational clinical trial

CORE-004: CLINICAL TREATMENT UNIT AND CLINICAL TRIALS PROCESSING LABORATORY (CTU/CTPL SR) PROJECT SUMMARY / ABSTRACT 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, directed by Dr. Larry Schaaf, is composed of two different units that are intimately related: the Clinical Treatment Unit (CTU) and the Clinical Trials Processing Laboratory (CTPL). The CTU/CTPL was established in 2004 to support and expand our ability to conduct early phase trials (CTU) and the supports the processing of biospecimens for any CTO-managed trial (CTPL). It has particular expertise for, and is strategically located, supporting the OSUCCC clinical trials, especially early phase trials; 42% of the CTPL activities are for early phase trials conducted in the CTU. The CTU/CTPL was formally reviewed as a new shared resource in 2009, where funding was only requested for the CTPL. (The OSUCCC funded the CTU from institutional support, and will continue to do so). The CTPL enhances the quality of research by providing dedicated staff for high volume procurement, processing, storage, delivery, and shipment of research biospecimens critical to the correlative studies component of OSUCCC clinical trials. Highly trained staff in the CTU/CTPL SR work closely with the Clinical Trials Office (CTO) and other shared resources to provide protocol review and feasibility assessment, specimen kit assembly and distribution of specimens to internal and external research laboratories. The Specific Aims of the CTU/CTPL are: 1) to 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) to 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 this previous grant cycle, the CTU has supported 142 protocols involving 1,354 patients with 14,490 patient visits, and the CTPL has procured and processed 82,454 research specimens on 381 protocols. During the past year, the CTU has supported 71 protocols involving 363 patients with 2,995 patient visits and the CTPL has procured and/or processed 17,875 research specimens on 216 protocols. During this time, 45 OSUCCC members, representing all five OSUCCC research programs, and accounting for 72% of the overall CTU/CTPL SR usage, have utilized the CTU/CTPL SR. The remainder of the usage was by clinical oncology faculty who work under the direct supervision of OSUCCC members. The CTPL has contributed to over 79 publications over the last five year grant period (16 with an impact factor > 10). The CTPL 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 early phase correlative studies. Expansion capacity is available given the additional space obtained by moving the CTU/CTPL to the new James Cancer Hospital, and the CTPL are considering expansion to additional clinical sites. The CTPL leverages extensive institutional support, and seeks only 18.9% support from CCSG funds. The Clinical Treatment Unit and Clinical Trials Processing Laboratory is part of the Clinical Grouping.

Core-004：临床治疗单元和临床试验处理实验室 （CTU/CTPL SR） 项目摘要 /摘要 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。由Larry Schaaf博士执导的CTU/CTPL SR由两个不同的单位组成 密切相关：临床治疗单元（CTU）和临床试验处理实验室（CTPL）。这 CTU/CTPL成立于2004年，以支持和扩大我们进行早期试验（CTU）和 支持任何CTO管理试验（CTPL）的生物测量处理。它具有特殊的专业知识， 并且具有战略地位，支持OSUCCC临床试验，尤其是早期试验； 42％ CTPL活动用于在CTU中进行的早期试验。 CTU/CTPL被正式审查为 2009年的新共享资源，仅要求CTPL资金。 （OSUCCC资助 来自机构支持的CTU，并将继续这样做）。 CTPL提高了研究质量 提供专门的工作人员，用于大量采购，处理，存储，交付和运输研究 OSUCCC临床试验的相关研究成分至关重要的生物测量。训练有素的员工 CTU/CTPL SR与临床试验办公室（CTO）和其他共享资源紧密合作以提供 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。 CTU/CTPL的具体目的是：1）提供稳定，可靠的， 以及经济高效的最先进的单位，用于进行早期临床试验，需要进行严格的监控 和/或复杂的相关标本收集； 2）提供高质量的高量标本 作为相相关组成部分收集的生物测量的处理，短期存储和分布 I，II和III转化临床试验。在上一个赠款周期中，CTU支持142个协议 涉及1,354例患者就诊的患者，CTPL采购并处理了82,454例研究 381个协议的标本。在过去的一年中，CTU支持了71种涉及363名患者的方案 有2,995次患者就诊，CTPL采购和/或处理了216的17,875个研究标本 协议。在此期间，有45位OSUCCC成员代表所有五个OSUCCC研究计划，以及 占整体CTU/CTPL SR使用情况的72％，已使用CTU/CTPL SR。其余的 在OSUCCC成员的直接监督下工作的临床肿瘤学教师的使用情况。这 CTPL在过去五年的赠款期间为79多个出版物做出了贡献（16个影响因素> 10）。 CTPL将继续提高OSUCCC进行的临床翻译研究的质量 通过提高效率，提高合规性和成本效益的集中支持早期的支持 相关研究。鉴于通过移动获得的额外空间，可以使用扩展能力 CTU/CTPL到新詹姆斯癌症医院，CTPL正在考虑扩展到其他临床 站点。 CTPL利用了广泛的机构支持，仅寻求CCSG资金的18.9％的支持。 临床治疗单元和临床试验处理实验室是临床组的一部分。