Clinical Trial Office

Ohio State University, Columbus OH

Investigators

Linked publications, trials & patents

Abstract

The OSUCCC Clinical Trials Office (CTO), rated "Excellent to Outstanding" in the 1999 review, supports the centralized administration of protocol conduct, development, review, implementation, monitoring, regulatory compliance, and quality assurance. The CTO is a shared resource of the OSUCCC that provides centralized management of all clinical trials conducted within the OSUCCC. The mission of the CTO is to foster a supportive environment conducive to the conduct of clinical trials by OSUCCC members and to provide a centralized resource to OSUCCC investigators for protocol administration, tracking and monitoring, data management, regulatory guidance, and financial management necessary for the successful conduct of clinical trials in a methodologically-sound, expedient, and cost-effective manner. The CTO came under the medical leadership o! John Byrd, M.D., and administrative leadership of Susan Ebert, R.D., M.S., in 2001. Since that time, the clinical research staff of Radiation Oncology, Stem Cell Transplant Program, Head & Neck Oncology, The Cancer and Leukemia Group B (CALGB), The AIDS-Related Malignancy Consortium (AMC), The CLL Research Consortium, and The NCI/CTEP Phase I Program have been consolidated within the CTO. This effort of consolidation as well as new clinical research faculty recruits and a consequent 232% increase in accrual to investigator-initiated studies (580 in 1999 and 1,926 in 2003) has resulted in the current CTO staffing of 38.5 FTE for its 224 open protocols, including 12 funded through NCI R21 QuickTrial grants. With recent acquisition of 7,000 nsf of space for the CTO, plans are to consolidate 20 remaining research staff conducting select cooperative group trials (ACOSOG, NSABP, and GOG) over the next two years in order to finalize centralization of all cancer clinical research activities. The CTO has reinforced infrastructure in the past several years with the creation of two new position titles, Regulatory Coordinator and Financial Manager. In addition, management infrastructure was improved with the creation of two new supervisory roles, the Clinical Research Manager (who manages all research nurses) and Data Management Supervisor (who manages research associates). A new web-based Cancer Research Information System (CRIS) has been developed for use by the CTO staff that vastly improves tracking of all research activities and provides the OSUCCC leadership and membership with the tools to monitor progress; 2627 patients were entered on trials and registered into the CTO CRIS database during the most recent 12-month period.