The OSUCCC Clinical Trials Office (CTO), rated""""""""Outstanding"""""""" in the 2004 review, supports the centralized administration of protocol development, implementation and conduct for all clinically active research groups. This shared resource provides the trial administration, protocol tracking and monitoring, data management, regulatory processing and financial supervision necessary for the successful conduct of clinical trials in a methodologically-sound, expedient, and cost-effective manner. The CTO came under the medical leadership of James P. Thomas, M.D., Ph.D. in 2005 and the administrative leadership of Janie Hofacker, R.N., B.S.N., M.S. in 2008. The incorporation of independent research groups into the CTO (1999-2004) combined with the ongoing growth of the clinical enterprise (1999-present) is responsible for the growth of the CTO from 38.5 FTEs at the time of the last CCSG submission to 90 FTEs currently. The growth of the CTO has facilitated a 89% increase in accrual to therapeutic clinical trials from 671 in 2004 to 1265 in the most recent 12-month period, 12/30/2008 - 11/30/2009. Accrual to interventional clinical trials has likewise increased 152% from 939 in 2004 to 2,274 in the same twelve months. In 2007, the CTO restructured the clinical coordinating staff into disease-specific teams to provide dedicated and efficient clinical trials support to clinical investigators specializing in the treatment of defined tumor types. This new structure mirrors the reinvlgorated disease-specific committee structure for clinical research implemented by the OSUCCC in 2004. The acquisition of 7,000 nsf of renovated space in Stariing-Loving Hall adjacent and connected to the James Cancer Hospital in 2005 has permitted the spatial centralization of CTO operations. Management infrastructure was improved with the creation of two new supervisory roles, the Clinical Research Manager (who manages all the coordinators within a disease team) and the Data Manager (who manages the data collection team). The creation of the Regulatory and Business Manager positions within the CTO has led to improved utilization of CTO resources. Also in 2007, web-based support for the management of CTO activities was significantly improved via implementation of the OnCore commercial clinical trial management (CTMS) software solution from Percipenz (Madison, Wl). The OnCore system is the most widely adopted CTMS among academic cancer centers across the United States and is actively being integrated with our CaBIG capabilities. This system provides for vastly improved tracking of all clinical research activities and provides CTO staff as well as OSUCCC leadership and membership with the tools to monitor all phases of the process of patient accrual and trial implementation. The CTO interacts with other CCC shared resources including the Biostatistics, Leukemia Tissue Bank, Clinical Trials Unit/Clinical Trials Processing Lab and Biorepository Biospecimen Shared Resources and supports the activities of the Clinical Scientific Review Committee and Data and Safety Monitoring Committee. The training and continuing education of clinical research staff and OSUCCC physicians is a central function of the CTO.

Public Health Relevance

The Clinical Trials Office shared resource provides centralized administration of all clinical trials conducted within the OSUCCC. This shared resource promotes the conduct of cancer clinical trials in a methodologically sound, compliant, expedient and cost-effective manner.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Ohio State University
United States
Zip Code
Byrd, John C; Ruppert, Amy S; Heerema, Nyla A et al. (2018) Lenalidomide consolidation benefits patients with CLL receiving chemoimmunotherapy: results for CALGB 10404 (Alliance). Blood Adv 2:1705-1718
Oblinger, Janet L; Burns, Sarah S; Huang, Jie et al. (2018) Overexpression of eIF4F components in meningiomas and suppression of meningioma cell growth by inhibiting translation initiation. Exp Neurol 299:299-307
Shu, Yi; Yin, Hongran; Rajabi, Mehdi et al. (2018) RNA-based micelles: A novel platform for paclitaxel loading and delivery. J Control Release 276:17-29
Scoville, Steven D; Nalin, Ansel P; Chen, Luxi et al. (2018) Human AML activates the aryl hydrocarbon receptor pathway to impair NK cell development and function. Blood 132:1792-1804
McMillan, Elizabeth A; Ryu, Myung-Jeom; Diep, Caroline H et al. (2018) Chemistry-First Approach for Nomination of Personalized Treatment in Lung Cancer. Cell 173:864-878.e29
Schimizzi, Gregory V; Jin, Linda X; Davidson 4th, Jesse T et al. (2018) Outcomes after vascular resection during curative-intent resection for hilar cholangiocarcinoma: a multi-institution study from the US extrahepatic biliary malignancy consortium. HPB (Oxford) 20:332-339
Fu, Xinping; Tao, Lihua; Wang, Pin-Yi et al. (2018) Comparison of infectivity and spread between HSV-1 and HSV-2 based oncolytic viruses on tumor cells with different receptor expression profiles. Oncotarget 9:21348-21358
Brewington, Beatrice Y; Shao, Yusra F; Davidorf, Fredrick H et al. (2018) Brachytherapy for patients with uveal melanoma: historical perspectives and future treatment directions. Clin Ophthalmol 12:925-934
Doogan, Nathan J; Cooper, Sarah; Quisenberry, Amanda J et al. (2018) The role of travel distance and price promotions in tobacco product purchase quantity. Health Place 51:151-157
McKenna, Mary K; Noothi, Sunil K; Alhakeem, Sara S et al. (2018) Novel role of prostate apoptosis response-4 tumor suppressor in B-cell chronic lymphocytic leukemia. Blood 131:2943-2954

Showing the most recent 10 out of 2602 publications