Clinical Treatment Unit & Clinical Trials Processing Laboratory

Ohio State University, Columbus OH

Investigators

Linked publications, trials & patents

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 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.