Administrative Supplement for VICKtOrY Early Clinical Trials Consortium

VICKtory 早期临床试验联盟的行政补充

• 批准号: 10392078
• 负责人: PATRICIA M. LORUSSO
• 金额: $ 10万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392078
• 关键词: Administrative Supplement; Area; Award; Back; Biological Markers; California; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Data; Development; Drug Delivery Systems; Drug Kinetics; Faculty; Florida; Funding; Geography; Goals; Grant; Infrastructure; Institution; Investigation; Investigational Therapies; Laboratories; Lead; Leadership; Letters; Malignant Neoplasms; Mentors; Mentorship; Methods; Minority Groups; Mission; Molecular; Notification; Oklahoma; Patient Recruitments; Patient Selection; Patient-Focused Outcomes; Patients; Pharmacodynamics; Pharmacopoeias; Phase; Philosophy; Population; Protocols documentation; Reporting; Research; Research Design; Research Personnel; Resistance; Rural Population; Science; Selection for Treatments; Serum; Services; Site; Special Population; Therapeutic; Toxic effect; Training; Translating; Translational Research; Translations; Universities; Variant; Washington; Work; Yale Cancer Center; biomarker-driven; career; clinical investigation; cohesion; cost; design; drug development; early phase clinical trial; early phase trial; follow-up; imaging biomarker; improved outcome; interest; member; next generation; novel; novel anticancer drug; novel therapeutic intervention; novel therapeutics; patient biomarkers; patient subsets; rare cancer; recruit; resistance mechanism; response; student mentoring; tissue biomarkers; translational medicine; treatment optimization; trial design; tumor

ABSTRACT: This application is being submitted to request additional funds for three Affiliated Organizations (AOs) to an NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) UM1 Lead Academic Organization. The purpose of the ETCTN is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly. As biomarker-driven trials become the cornerstone of early phase investigation, allowing for the study of potential mechanisms of response and resistance, incorporation of these biomarkers is lending itself to novel trial designs which incorporate fewer, and often rarer patient subsets, defining greater patient outcomes with smaller recruited populations. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. In 2020, we were awarded a UM1 grant (2UM1CA186689) which was a re-competition of a previous ETCTN UM1 award, demonstrating both our progress over the past funding period as well as our capabilities to conduct early phase clinical trials. In response to a notification from the NCI Cancer Therapy Evaluation Program (CTEP), we are submitting this administrative supplement to offset some of the costs of absorbing three additional AOs leading active ETCTN clinical trials but which were not included in our original funded ETCTN UM1 Type 2 award. These centers were added to our consortium in the interest of providing continuity for productive ETCTN sites leading active trials (those with patients on ETCTN trials in treatment and in follow-up). Our original partnerships included Vanderbilt-Ingram, University of California San Diego, University of Oklahoma Stephenson Cancer Center and the Yale Cancer Center (VICtOrY). We have added Columbia University, Washington University in St. Louis, and the University of Florida to this consortium to form VICtOrY-CWF. Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 10% underserved/special populations. The members of our team, along with the proposed additional sites, have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. Together, VICtOrY-CWF is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.

摘要：正在提交此应用程序向三个关联组织请求额外资金 （AOS）到NCI实验性治疗式临床试验网络（ETCTN）UM1 LEAD Academic 组织。 ETCTN的目的是开发新的治疗选择，同时定义更好 开发新型抗癌剂的方法，这些抗癌剂利用了表征肿瘤的能力 分子。随着生物标志物驱动的试验成为早期调查的基石，允许 研究反应和抗性的潜在机制，这些生物标志物的掺入正在自身借给 新颖的试验设计，其中包含更少，通常更稀有的患者子集，定义了更大的患者预后 与较小的招募人群。结果，诸如ETCTN之类的独特网络，由多个 需要以科学驱动的网站和具有大量专业知识的研究人员。在2020年，我们被授予 UM1赠款（2UM1CA186689），是对以前的ETCTN UM1奖的重新竞争 我们在过去的资金期间的进步以及我们进行早期临床试验的能力。 为了回应NCI癌症治疗评估计划（CTEP）的通知，我们正在提交 行政补充以抵消吸收另外三个AOS领先活跃ETCTN的一些成本 临床试验，但不包括我们原始资助的ETCTN UM1 2型奖。这些中心是 为了为生产性ETCTN站点提供连续性，添加到我们的联盟中 （患有ETCTN的患者在治疗和随访中的患者）。我们最初的伙伴关系包括 加州大学圣地亚哥分校，俄克拉荷马大学斯蒂芬森癌症中心和 耶鲁癌症中心（胜利）。我们添加了圣路易斯华盛顿大学的哥伦比亚大学 佛罗里达大学进入该财团，形成胜利-CWF。我们的团队的目标是1）利用小说 使用CTEP Pharmacopeia，在罕见的癌症中转化为早期试验的科学发现， 普通癌症的常见癌症和罕见的变体； 2）结合血清，组织和成像 生物标志物可以更好地理解单独或组合新型药物的影响； 3）火车早期职业 通过提供临床的研究人员，知识渊博并精通早期临床试验 研究领导机会和指导； 4）包括我们早期临床试验的组成部分 招募，服务不足/特殊人群不少于10％。我们团队的成员以及 拟议的其他站点，具有独特的互补专业知识，并且具有类似的理念 下一代癌症研究者的合作研究和指导。在一起，胜利-CWF 致力于利用我们的专业领域，将科学整合到我们的机构中​​，并最大化我们的 与最终任务进行ETCTN内部进行尖端的早期试验的协作关系 改善癌症患者的预后。