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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016058-38
Application #
8601835
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
38
Fiscal Year
2014
Total Cost
$548,445
Indirect Cost
$188,808
Name
Ohio State University
Department
Type
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
Bolyard, Chelsea; Meisen, W Hans; Banasavadi-Siddegowda, Yeshavanth et al. (2017) BAI1 Orchestrates Macrophage Inflammatory Response to HSV Infection-Implications for Oncolytic Viral Therapy. Clin Cancer Res 23:1809-1819
Schuh, Elizabeth M; Portela, Roberta; Gardner, Heather L et al. (2017) Safety and efficacy of targeted hyperthermia treatment utilizing gold nanorod therapy in spontaneous canine neoplasia. BMC Vet Res 13:294
Kumar, Bhavna; Yadav, Arti; Brown, Nicole V et al. (2017) Nuclear PRMT5, cyclin D1 and IL-6 are associated with poor outcome in oropharyngeal squamous cell carcinoma patients and is inversely associated with p16-status. Oncotarget 8:14847-14859
Miller, Cecelia R; Ruppert, Amy S; Fobare, Sydney et al. (2017) The long noncoding RNA, treRNA, decreases DNA damage and is associated with poor response to chemotherapy in chronic lymphocytic leukemia. Oncotarget 8:25942-25954
Pearlman, Rachel; Frankel, Wendy L; Swanson, Benjamin et al. (2017) Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients With Early-Onset Colorectal Cancer. JAMA Oncol 3:464-471
Farren, Matthew R; Hennessey, Rebecca C; Shakya, Reena et al. (2017) The Exportin-1 Inhibitor Selinexor Exerts Superior Antitumor Activity when Combined with T-Cell Checkpoint Inhibitors. Mol Cancer Ther 16:417-427
Teng, Kun-Yu; Han, Jianfeng; Zhang, Xiaoli et al. (2017) Blocking the CCL2-CCR2 Axis Using CCL2-Neutralizing Antibody Is an Effective Therapy for Hepatocellular Cancer in a Mouse Model. Mol Cancer Ther 16:312-322
Russell, Luke; Bolyard, Chelsea; Banasavadi-Siddegowda, Yeshavanth et al. (2017) Sex as a biological variable in response to temozolomide. Neuro Oncol 19:873-874
Terrazas, Cesar; de Dios Ruiz-Rosado, Juan; Amici, Stephanie A et al. (2017) Helminth-induced Ly6Chi monocyte-derived alternatively activated macrophages suppress experimental autoimmune encephalomyelitis. Sci Rep 7:40814
Saporito, Donika; Brock, Pamela; Hampel, Heather et al. (2017) Penetrance of a rare familial mutation predisposing to papillary thyroid cancer. Fam Cancer :

Showing the most recent 10 out of 2211 publications