EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-011)

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Harold C. Simmons Cancer Center Early Phase Clinical Research Support (EPCRS) Project Summary/Abstract One of the highest priorities of the Simmons Cancer Center is to effectively translate UT Southwestern (UTSW) scientific discoveries to the clinic. Translating these discoveries into clinical benefit often requires pre-clinical investigations to generate preliminary data needed to support clinical investigation. Funding this preclinical work has been difficult, since there are a number of costs associated with generation of preliminary data which are often unfunded by external sources. These include purchasing of imaging time; PK/PD studies; pre-and post-biopsies to assess biomarkers; determining a dosing regimen to be used in a clinical trial; development of novel imaging probes that provide functional and metabolic information. Early phase investigator-initiated translational research trials require significant regulatory, data management and research nursing resources that are not always available through traditional mechanisms in a timely fashion. The primary goals of the Cancer Center's Early Phase Clinical Research Support is to provide support to Cancer Center members for innovative pilot or Phase I studies, so as to capitalize on the science being carried out in the scientific programs. Only protocols which are investigator initiated, based on UTSW science, and likely to result in Phase II or III studies, will be funded. In 2013, we strengthened our Phase 1 program by recruiting an experienced Phase 1 Leader, Arthur Frankel, M.D., and provided dedicated space and personnel — a manager, research nurse and coordinators, data specialists, a dedicated senior regulatory associate, an administrative assistant and a protocol administrator to facilitate expansion of our phase 1 activities including investigator-initiated trials. This focus has led to an overall increase in accrual to all investigator-initiated early phase trials from 47 in 2009 to 231 in 2013, with an increase in accrual to investigator-initiated early phase studies supported by these personnel from 8 patients in 2010 to 65 in 2013.