Vanderbilt Network Lead Academic Participating Site for the NCTN

项目摘要/摘要 范德比尔特-英格拉姆癌症中心(VICC)是范德比尔特大学医学中心内的一个基质癌症中心 (VUmc)。VICC作为合作小组系统的一部分已有27年多的历史，也是一位领先的学者 参与网站自国家临床试验网络(NCTN)成立以来。多年来，我们 已将我们的医生纳入领导角色，并将我们的基础科学纳入研究人员发起的试验，如 以及招募病人进行临床试验。此外，VICC在领导方面有着长期的记录， 科学和管理，在合作小组/NCTN内，并帮助初级教员进行临床试验 发展。VICC为NCTN带来了巨大的优势，包括两个孢子赠款，一个EDRN赠款，一个世界 影像科学一流研究所、八大科学计划和一项早期治疗临床 试验网络(ETCTN)赠款，成功的早期试验可以整合到NCTN中。我们的 个人化癌症医学倡议(PCMI)致力于将适当的治疗与基因匹配 正在推动癌症生长的变化或突变，一个活跃的研究组成部分正在调查 靶向治疗的耐药机制。VICC PCMI的关键信息学是MyCancerGenome， 这个网站不仅向医生通报了癌症基因组学的最新进展，而且还提供了治疗癌症的试验 其肿瘤存在可操作的基因改变的患者。随着PD-1/PD-L1抑制剂的发展 随着新的免疫疗法的出现，VICC已经招募了免疫学方面的顶级研究人员。那些上衣 研究人员与VUMC的其他调查人员合作，创建了范德比尔特感染研究所， 免疫学和炎症(VI4)，总体使命是培养下一代科学家和 医生，并在感染生物学、免疫学和炎症领域取得根本性发现 以增加知识和改善人类健康为目标。VICC临床医生和科学家 并将继续为NCTN的目标做出重大贡献 目的是改善癌症患者的预后。 国际刑事法院选择乔丹·伯林博士为首席调查员，继续领导 该机构将其科学、学术和患者资源整合到NCTN中。他被卷入其中 在临床试验、指导和领导方面广泛参与合作小组/NCTN。协助 柏林博士通过执行这笔赠款，VICC创建了两个顾问委员会，内部顾问委员会(IAB)和 NCTN执行委员会(NEC)，其成员包括医学学科的广泛代表 以及VICC和VUMC的疾病利益。IAB确保赠款的最佳使用，如预算 审查，确保多学科参与，并参与整个NCTN。NEC实施了 业务职能，如开庭审理、预提和指导。在行动上，NEC积极地 管理NCTN试验的开始、应计和跨学科和小组的参与。IAB和NEC 致力于将VICC科学融入NCTN。VICC临床试验共享资源及其NCTN团队 确保法规、生物检疫、放射学和数据提交的及时性和高度准确性。 进一步推进NCTN与VICC临床研究企业整合的广泛计划 VICC对NCTN的研究在拨款中有详细说明，包括新任命柏林博士担任 临床研究战略和共享资源副主任。这是VICC的新角色， 旨在协调所有VICC计划的临床研究优先事项，并增加 将VICC科学转化为临床试验。对于这笔赠款，柏林博士的新角色将有助于加强 对整个机构的NCTN试验进行优先排序。

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.