Vanderbilt Network Lead Academic Participating Site for the NCTN

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PROJECT SUMMARY/ABSTRACT Vanderbilt-Ingram Cancer Center (VICC) is a matrix cancer center within Vanderbilt University Medical Center (VUMC). VICC has been part of the cooperative group system for over 27 years, and a Lead Academic Participating Site since the inception of the National Clinical Trials Network (NCTN). Throughout the years, we have integrated our physicians into leadership roles and our basic science into investigator-initiated trials, as well as enrolled patients onto clinical trials. Additionally, VICC has a long track record of leadership, both scientific and administrative, within the cooperative groups/NCTN, and helping junior faculty in clinical trial development. VICC brings great strengths to the NCTN, including two SPORE grants, an EDRN grant, a world class Institute of Imaging Science, eight highly funded scientific programs and an Early Therapeutics Clinical Trial Network (ETCTN) grant where successful early phase trials can be integrated into the NCTN. Our Personalized Cancer Medicine Initiative (PCMI) is dedicated to matching the appropriate therapy to the genetic changes, or mutations, that are driving the growth of cancers, with an active research component investigating mechanisms of resistance to targeted therapies. The key informatics of the VICC PCMI is MyCancerGenome, a website that not only informs physicians on the latest in cancer genomics, but also the availability of trials for patients whose tumors harbor actionable genetic alterations. With the development of PD-1/PD-L1 inhibitors and novel immune therapies on the horizon, VICC has recruited top researchers in immunology. Those top researchers in collaboration with other VUMC investigators created the Vanderbilt Institute for Infection, Immunology and Inflammation (VI4) with an overall mission to train the next generation scientists and physicians and make fundamental discoveries in the areas of infection biology, immunology and inflammation with the goal of increasing knowledge and improving human health. VICC clinicians and scientists are academic leaders in their respective disciplines and will continue to significantly contribute to the NCTN goals with the objective to improve the outcomes for cancer patients. The VICC selected Dr. Jordan Berlin, MD, as Principal Investigator to continue leading the efforts of the institution to integrate its scientific, academic and patient resources into the NCTN. He has been involved extensively in the cooperative groups/NCTN in conduct of clinical trials, mentorship and leadership. To assist Dr. Berlin with the conduct of this grant, VICC created two advisory boards, Internal Advisory Board (IAB) and NCTN Executive Committee (NEC), whose membership includes a broad representation of medical disciplines and disease interests across VICC and VUMC. The IAB assures the optimal use of the grant, such as budget review, assuring multidisciplinary involvement, and participation throughout the NCTN. The NEC implements operational functions, such as trial opening, accrual and mentoring. Operationally, the NEC has actively managed NCTN trial opening, accruals and participation across disciplines and groups. Both the IAB and NEC work to integrate VICC science into the NCTN. The VICC Clinical Trials Shared Resource and its NCTN team ensures that regulatory, biospecimen, radiology and data submissions are timely and highly accurate. An extensive plan to further advance the integration of the NCTN into the VICC clinical research enterprise and VICC research into the NCTN is detailed in the grant, including the new appointment of Dr. Berlin to the role of Associate Director for Clinical Research Strategy and Shared Resources. This is a new role for VICC, designed to allow coordination of clinical research priorities across all VICC programs and to increase the translation of VICC science into clinical trials. For this grant, Dr. Berlin’s new role will help to strengthen the prioritization of NCTN trials across the institution.