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

点击翻译按钮获取中文摘要

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.