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.
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.
|Salem, Galena; Ruppert, Amy S; Elder, Patrick et al. (2015) Lower dose of antithymocyte globulin does not increase graft-versus-host disease in patients undergoing reduced-intensity conditioning allogeneic hematopoietic stem cell transplant. Leuk Lymphoma 56:1058-65|
|Niederwieser, C; Kohlschmidt, J; Volinia, S et al. (2015) Prognostic and biologic significance of DNMT3B expression in older patients with cytogenetically normal primary acute myeloid leukemia. Leukemia 29:567-75|
|Billingsley, Caroline C; Cohn, David E; Mutch, David G et al. (2015) Polymerase ? (POLE) mutations in endometrial cancer: clinical outcomes and implications for Lynch syndrome testing. Cancer 121:386-94|
|Krok-Schoen, Jessica L; Kurta, Michelle L; Weier, Rory C et al. (2015) Clinic type and patient characteristics affecting time to resolution after an abnormal cancer-screening exam. Cancer Epidemiol Biomarkers Prev 24:162-8|
|Biddle, Martha J; Lennie, Terry A; Bricker, Gregory V et al. (2015) Lycopene dietary intervention: a pilot study in patients with heart failure. J Cardiovasc Nurs 30:205-12|
|Jin, Ming; Roth, Rachel; Rock, Jonathan B et al. (2015) The impact of tumor deposits on colonic adenocarcinoma AJCC TNM staging and outcome. Am J Surg Pathol 39:109-15|
|Llanos, Adana A; Pennell, Michael L; Young, Gregory S et al. (2015) No association between colorectal cancer worry and screening uptake in Appalachian Ohio. J Public Health (Oxf) 37:322-7|
|Nguyen, Huyen T; Jia, Guang; Shah, Zarine K et al. (2015) Prediction of chemotherapeutic response in bladder cancer using K-means clustering of dynamic contrast-enhanced (DCE)-MRI pharmacokinetic parameters. J Magn Reson Imaging 41:1374-82|
|Berman-Booty, Lisa D; Thomas-Ahner, Jennifer M; Bolon, Brad et al. (2015) Extra-prostatic transgene-associated neoplastic lesions in transgenic adenocarcinoma of the mouse prostate (TRAMP) mice. Toxicol Pathol 43:186-97|
|Pant, Shubham; Martin, Ludmila K; Geyer, Susan et al. (2014) Baseline serum albumin is a predictive biomarker for patients with advanced pancreatic cancer treated with bevacizumab: a pooled analysis of 7 prospective trials of gemcitabine-based therapy with or without bevacizumab. Cancer 120:1780-6|
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