UT Southwestern NCI National Clinical Trials Network Lead Academic Site

UT 西南 NCI 国家临床试验网络领先学术网站

• 批准号: 10581694
• 负责人: David Eric Gerber
• 金额: $ 77.96万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-22 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581694
• 关键词: Academic Medical Centers; Administrative Supplement; Adult; African American; Area; Basic Science; Bioinformatics; Cancer Center; Categories; Clinic; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Colorectal Cancer; Comprehensive Cancer Center; Conduct Clinical Trials; Country; Disease; Eligibility Determination; Enrollment; Faculty; Funding; Grant; Growth; Health Resources; Hispanic; Hospitals; Image; Investigational Therapies; Lead; Leadership; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malignant neoplasm of lung; Medical center; Mentors; NCI-Designated Cancer Center; National Clinical Trials Network; Outcomes Research; Patient-Focused Outcomes; Patients; Population; Population Heterogeneity; Population Research; Positioning Attribute; Process; Publications; Race; Radioisotopes; Recording of previous events; Renal carcinoma; Research; Role; Site; Texas; Therapeutic; Time; Translating; Universities; base; career development; clinical research site; clinical trial enrollment; cost; design; drug discovery; ethnic diversity; ethnic minority; innovation; medical schools; member; metropolitan; novel; participant enrollment; pressure; programs; racial minority; screening; timeline

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.

项目总结/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）。UG 1应用程序的领导者和其他教职员工 担任主要的NCTN角色，包括主持临床试验和委员会。2014年3月至8月 2017年，UTSW在13个疾病类别的成人NCTN试验中招募了520名患者。在此期间，UTSW 教师撰写或共同撰写了27篇与NCTN试验直接相关的出版物，并主持，共同主持，或 在13次合作小组试验中担任合作小组委员会主席。近期大幅增长 使UTSW能够扩大应计和科学贡献。在2010年获得最初的NCI认定后， 哈罗德C。西蒙斯癌症中心于2015年获得全面指定。自2015年以来，两个新 附属于南威尔士大学的医院已经建成。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;一个先进的成像研究中心;和一个以患者为中心的 成果研究中心。作为美国唯一的学术医疗中心和医学院， 达拉斯/英尺沃思（DFW）大都会（人口720万）和唯一的NCI指定的综合癌症 中心在北德克萨斯州，UTSW达到了一个庞大而多样化的人口，否则将无法获得 NCTN试验。近年来，在NCTN临床研究中，高达29%的患者是西班牙裔， 21%是非洲裔美国人。UTSW UG 1的具体目标如下：目标1。贡献 NCTN试验累积。我们将继续招募具有不同种族和种族背景的患者， 治疗和非治疗试验。目标2.为NCTN的科学方向做出贡献。我们将带来UTSW 基础、转化和影像学研究转化为假设驱动的临床试验。目标3。提供NCTN 领导UTSW教师将继续主持和共同主持临床试验和委员会在各种 NCTN团体，并参与NCI的活动和倡议。目标4。促进职业发展 初级教员和实习生UTSW教师将在NCTN提供指导和指导。目标5。支持 NCTN的行政工作。UTSW教师将继续服务于NCTN和NCI监管和审计 委员会。在多个步骤中，癌症临床研究的设计和实施变得更加复杂。 挑战性财政压力限制了全国范围内临床研究者的受保护时间。增加 临床试验的成本和复杂性延长了激活时间表并限制了资格。UTSW蓄势待发 来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， 以及不断增长的生物信息学能力，以优化临床 试验对象。总之，这些方法使UTSW能够继续帮助领导和扩大NCTN的工作。