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: 10062108
• 负责人: David Eric Gerber
• 金额: $ 12万
• 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/10062108
• 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; Hispanics; 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; Radioisotopes; Recording of previous events; Renal carcinoma; Research; Role; Site; Texas; Therapeutic; Time; TimeLine; Translating; Universities; base; career development; clinical research site; clinical trial enrollment; cost; design; drug discovery; ethnic diversity; ethnic minority population; innovation; medical schools; member; metropolitan; novel; pressure; programs; racial and ethnic; racial minority; screening

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.

项目概要/摘要 多年来，德克萨斯大学西南医学中心 (UTSW) 在以下领域发挥了关键领导作用： 国家临床试验网络（NCTN）。本次UG1申报的领导及其他教职人员 担任 NCTN 的主要职务，包括主持临床试验和委员会。从 2014 年 3 月到 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。在那段时间，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，并曾主持、共同主持或 担任13个合作组试验的合作组委员会主席。近期大幅增长 使 UTSW 能够扩大应计和科学贡献。在 2010 年获得初始 NCI 指定后， Harold C. Simmons 癌症中心于 2015 年获得综合指定。自 2015 年以来，两个新的 UTSW 附属医院已建成。我们拥有充满活力的药物发现计划；孢子 肺癌和肾癌的资助；先进成像研究中心；和以患者为中心的 结果研究 (PCOR) 中心。作为美国唯一的学术医疗中心和医学院 达拉斯/英尺。沃斯 (DFW) Metroplex（人口 720 万）和唯一 NCI 指定的综合癌症中心 UTSW 位于德克萨斯州北部中心，拥有大量多样化的人口，否则这些人口将无法接触到 NCTN 试验。近年来，参加 NCTN 临床研究的患者中有高达 29% 是西班牙裔，并且 高达 21% 是非裔美国人。 UTSW UG1 的具体目标如下： 目标 1. 贡献 NCTN 试用累积。我们将继续招募具有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 假设驱动的临床试验的基础、转化和成像研究。目标 3. 提供 NCTN 领导。 UTSW 教师将继续主持和共同主持各个领域的临床试验和委员会 NCTN 团体，并参与 NCI 的活动和倡议。目标 4. 促进职业发展 初级教师和实习生。 UTSW 教师将在 NCTN 提供指导和指导。目标 5. 支持 NCTN 行政努力。 UTSW 教职人员将继续在 NCTN 和 NCI 监管和审计部门任职 委员会。通过多个步骤，癌症临床研究的设计和实施变得更加 具有挑战性的。财政压力限制了全国范围内临床研究人员的受保护时间。增加 临床试验的成本和复杂性延长了启动时间并限制了资格。 UTSW已蓄势待发 迎接并克服这些挑战。通过指定的资助和指导计划，我们继续 培养临床研究者和疾病专家。我们利用了庞大且多样化的患者基础， 以及不断增长的生物信息学能力，以优化临床药物的识别、筛选和登记 试验对象。这些方法共同使 UTSW 能够继续帮助领导和扩大 NCTN 的工作。