UT Southwestern NCI National Clinical Trials Network Lead Academic Site

项目摘要/摘要 多年来，德克萨斯大学西南医学中心(UTSW)在 国家临床试验网络(NCTN)。该UG1应用程序的负责人和其他教职员工 担任NCTN的主要职务，包括主持临床试验和委员会。2014年3月至8月 2017年，UTSW招募了520名患者参加13个疾病类别的成人NCTN试验。在此期间，UTSW 教职员工撰写或共同撰写了27篇与NCTN试验直接相关的出版物，并担任过主席、联合主席或 在13个合作组试验中担任合作组委员会主席。近期大幅增长 定位UTSW以扩大应计和科学贡献。在2010年收到初始NCI指定后， 哈罗德·C·西蒙斯癌症中心于2015年获得全面称号。自2015年以来，有两个新的 UTSW附属医院已经建成。我们有一个充满活力的药物发现计划；孢子 肺癌和肾癌的赠款；高级成像研究中心；以及以患者为中心 成果研究(PCOR)中心。作为全国唯一的学术医学中心和医学院 达拉斯/堡垒沃思(DFW)Metroplex(人口720万)和唯一被NCI指定为综合性癌症 位于德克萨斯州北部的UTSW中心，覆盖了大量多样化的人口，否则他们将无法获得 NCTN试验。近年来，参加NCTN临床研究的患者中，高达29%是西班牙裔，并且 高达21%的人是非裔美国人。UTSW UG1的具体目标如下：目标1.贡献 到NCTN试验应计费用。我们将继续招收不同民族和种族背景的患者 治疗性和非治疗性试验。目标2.为NCTN的科学方向做出贡献。我们将带来UTSW 以假设为导向的临床试验的基础研究、转化研究和成像研究。目标3.提供NCTN 领导力。UTSW的教职员工将继续担任各种临床试验和委员会的主席和联合主席 NCTN团体，并通过参与NCI活动和倡议。目标4.促进职业发展 初级教职员工和实习生。UTSW的教职员工将在NCTN提供指导和指导。目标5.支持 NCTN的管理努力。UTSW教员将继续在NCTN和NCI监管和审计部门任职 委员会。在多个步骤中，癌症临床研究的设计和实施已变得更加 很有挑战性。财政压力限制了全国临床研究人员的保护时间。渐增 临床试验的成本和复杂性延长了激活时间，限制了资格。UTSW已做好准备 迎接和克服这些挑战。通过指定的资金和指导计划，我们将继续 培养临床研究人员和疾病专家。我们利用了庞大而多样化的患者基础，如 以及不断增长的生物信息学能力，以优化临床患者的识别、筛选和登记 受试者。总而言之，这些方法使UTSW能够继续帮助领导和扩大NCTN的努力。

PROJECT SUMMARY/ABSTRACT For years, the University of Texas Southwestern Medical Center (UTSW) has provided key leadership within the National Clinical Trials Network (NCTN). The leaders of this UG1 application and other faculty members hold major NCTN roles, including chairing clinical trials and committees. From March 2014 through August 2017, UTSW enrolled 520 patients on adult NCTN trials across 13 disease categories. During that time, UTSW faculty authored or co-authored 27 publications directly related to NCTN trials, and have chaired, co-chaired, or served as cooperative group committee chairs on 13 cooperative group trials. Substantial recent growth positions UTSW to expand accrual and scientific contributions. After receiving initial NCI designation in 2010, the Harold C. Simmons Cancer Center received comprehensive designation in 2015. Since 2015, two new hospitals affiliated with UTSW have been constructed. We have a vibrant drug discovery program; SPORE grants in lung cancer and kidney cancer; an Advanced Imaging Research Center; and a Patient Centered Outcomes Research (PCOR) Center. As the only academic medical center and medical school in the Dallas/Ft. Worth (DFW) Metroplex (population 7.2 million) and the only NCI-designated Comprehensive Cancer Center in North Texas, UTSW reaches a large and diverse population that otherwise would not have access to NCTN trials. In recent years, up to 29% of our patients enrolled on NCTN clinical studies were Hispanic, and up to 21% were African American. The specific aims of the UTSW UG1 are the following: Aim 1. Contribute to NCTN trial accrual. We will continue to enroll patients with diverse ethnic and racial backgrounds on therapeutic and non-therapeutic trials. Aim 2. Contribute to NCTN scientific direction. We will bring UTSW basic, translational, and imaging research into hypothesis-driven clinical trials. Aim 3. Provide NCTN leadership. UTSW faculty will continue to chair and co-chair clinical trials and committees in the various NCTN groups, and by participate in NCI activities and initiatives. Aim 4. Promote career development of junior faculty and trainees. UTSW faculty will provide mentoring and guidance in the NCTN. Aim 5. Support NCTN administrative efforts. UTSW faculty will continue to serve on NCTN and NCI regulatory and auditing committees. At multiple steps, the design and conduct of cancer clinical research has become more challenging. Financial pressures have limited the protected time of clinical investigators nationwide. Increasing cost and complexity of clinical trials has prolonged activation timelines and restricted eligibility. UTSW is poised to meet and overcome these challenges. With designated funding and mentoring programs, we continue to develop clinical investigators and disease experts. We have capitalized on a large and diverse patient base, as well as growing bioinformatics capabilities, to optimize the identification, screening, and enrollment of clinical trial subjects. Together, these approaches position UTSW to continue to help lead and expand NCTN efforts.