EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-017)

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CORE 017: EARLY PHASE CLINICAL RESEARCH SUPPORT PROJECT SUMMARY/ABSTRACT The overall goal of Early Phase Clinical Research Support (EPCRS) is to catalyze and sustain innovative clinical studies of novel therapies or devices conducted by Vanderbilt-Ingram Cancer Center (VICC) members. VICC investigators have contributed significantly to the understanding of drivers of neoplasia, oncogene addiction, de novo and acquired drug resistance and predictive biomarkers of drug action. EPCRS funds have been essential to the execution of several innovative trials focused on these themes. Twelve investigator- initiated trials (IITs) have been supported by EPCRS during the last funding period. These have generated additional grant support and publications as well as led to larger late phase clinical trials. The Resource Allocation Committee (RAC), created by VICC in 2007, manages the distribution of EPCRS funds from the CCSG and VICC institutional funds to IITs based on scientific merit and priorities of the Center. This is done following review by a committee composed of faculty from multiple cancer disciplines represented in VICC including medical, surgical, radiation and pediatric oncology, cancer genomics, translational research, non-invasive imaging. Criteria used to determine allocation of EPCRS funds mainly include: supportive preclinical data from VICC members, potential to lead to larger multi-institutional pivotal phase II/III trials and extramural funding, feasibility, originality, novel molecular and imaging correlatives, and mentorship for junior investigators. Management of awarded funds is closely monitored by the Medical Director of the Clinical Trials Shared Resource (CTSR), RAC Chairperson, Finance Office, and Human Resources and evaluated on a quarterly basis. Several VICC initiatives and institutional interactions support an excellent environment for the generation of clinical trials potentially eligible for EPCRS support currently and during the next funding period. These include the Center for Targeted Therapies (C2T2), the Innovative Translational Research (ITR) Shared Resource, the Next Generation Sequencing (NGS) Working Group, the Vanderbilt Cancer Imaging Support Laboratory (CISL), the Vanderbilt University Institute of Imaging Sciences (VUIIS) and the Vanderbilt Institute of Chemical Biology (VICB). The C2T2 hosts and coordinates Molecular Tumor Boards, a Visiting Professor (ViP) seminar series, C2T2-Pharma Colloquia, and C2T2 Studios, all representing a source of applications seeking support by EPCRS. These funds also support early phase trials that can lead to larger trials within the National Clinical Trials Network (NCTN), where VICC was awarded a Lead Academic Participating Site (LAPS) grant. During the last funding period, EPCRS has continued to support VICC investigators in the use of their expertise in precision medicine and early drug development.