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申请和其他教职员工的领导者 担任主要NCTN职务，包括主席临床试验和委员会。从2014年3月到八月 2017年，UTSW在13个疾病类别中招募了520名成人NCTN试验患者。在此期间，UTSW 教师撰写或合着了27个与NCTN试验直接相关的出版物，并主持，主持或 在13项合作小组审判中担任合作小组委员会主席。最近的增长 位置UTSW扩大应计和科学贡献。在2010年收到最初的NCI指定后， Harold C. Simmons癌症中心于2015年获得了全面的名称。自2015年以来，两个新的 已建立了隶属于UTSW的医院。我们有一个充满活力的药物发现计划；孢子 肺癌和肾癌的补助；先进的成像研究中心；和患者以中心为中心 结果研究（PCOR）中心。作为唯一的学术医学中心和医学院 达拉斯/英尺。价值（DFW）Metroplex（人口720万），也是NCI指定的综合癌症 UTSW的北德克萨斯州中心到达众多的人口，否则将无法进入 NCTN试验。近年来，多达29％的NCTN临床研究患者是西班牙裔，并且 多达21％的非裔美国人。 UTSW UG1的具体目的如下：目标1。贡献 应计NCTN试验。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。促进NCTN科学方向。我们将带上UTSW 对假设驱动的临床试验的基本，翻译和成像研究。目标3。提供NCTN 领导。 UTSW教职员工将继续主持和联合主席临床试验和各种委员会 NCTN组，并参加NCI活动和计划。目标4。促进职业发展 初级教师和学员。 UTSW教师将在NCTN中提供指导和指导。目标5。支持 NCTN的行政工作。 UTSW教职员工将继续在NCTN和NCI监管和审计上任职 委员会。在多个步骤中，癌症临床研究的设计和行为已变得更加 具有挑战性的。财务压力限制了全国临床调查人员的受保护时间。增加 临床试验的成本和复杂性已延长激活时间表和限制资格。 UTSW是镇定的 满足并克服这些挑战。通过指定的资金和指导计划，我们继续 发展临床研究人员和疾病专家。我们已经利用了一个大而多样化的患者基础， 以及增强生物信息学能力，以优化临床的识别，筛查和注册 试用对象。这些方法共同定位UTSW，以继续帮助领导和扩大NCTN的努力。