Early Phase Clinical Research Support

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EARLY PHASE CLINICAL RESEARCH SUPPORT (EPCRS) ABSTRACT Early Phase Clinical Research Support (EPCRS) at the University of New Mexico Cancer Center (UNMCC), led by Olivier Rixe, MD, PhD, supports the development and the conduct of early phase investigator-initiated trials (IITs). The goal of ECPRS is to increase the pace at which discoveries by UNMCC members are translated into the design and conduct of innovative early phase investigator-initiated trials that are accessible to all New Mexicans. This objective is supported by the cutting-edge, cancer-focused research in the four UNMCC Research Programs, in particular the translational pipeline developed in the Cancer Therapeutics: Technology, Discovery, and Targeted Delivery (CT) Program, and the UNMCC clinical research infrastructure that includes the Clinical Trials Office, Shared Resources and the New Mexico Cancer Care Alliance (NMCCA), a UNMCC-based statewide cancer clinical trials network. In the current funding period, the UNMCC used Cancer Center Support Grant (CCSG) Developmental Funds in combination with funds from other UNMCC sources to supplement CCSG-supported Early Phase Clinical Research Support (formerly known as Protocol Specific Research Support (PSRS)) to provide the clinical research infrastructure and funding for associated-laboratory studies for early phase clinical trials that were designed by UNMCC members. Since 2010, 10 Phase 0 and Phase I studies have been supported by UNMCC. In 2013, 28 patients were enrolled on 3 pilot Phase I institutional clinical trials. These IITs all resulted from research findings by UNMCC members and involved different protein targets from multiple pathways (GTPases, DNA repair proteins, integrins) in a large variety of cancers (ovary, leukemia, ovarian cancer, head and neck squamous cell carcinoma and other solid tumors). Following guidance from the UNMCC External Advisory Committee, several major changes have been implemented to enhance early phase clinical research at the UNMCC. Olivier Rixe, MD, PhD, an expert in early phase clinical trials and drug development, was recruited as Associate Director for Clinical Research, joining the UNMCC on July 1, 2014. The infrastructure for the UNMCC Phase I unit has also been reorganized and expanded to enhance the impact of the EPCRS component. Processes have been established to stimulate direct collaborations between the UNMCC Clinical Working Groups and the four UNMCC Research Programs that focus on the development of novel concepts for early phase clinical trials based on research findings by UNMCC members. These concepts will be evaluated using a unique prioritization system involving the Clinical Working Groups and the Protocol Review and Monitoring Committee. The UNMCC has committed $500,000 per year from other funding sources in addition to the requested CCSG funds for EPCRS, with the goal of increasing the proportion of novel and innovative early phase investigator-initiated studies within the UNMCC clinical trial portfolio. More than 27 concepts are currently being investigated for further clinical development.