The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies

约翰·霍普金斯大学转化科学团队和 ETCTN 研究联盟

• 批准号: 10784843
• 负责人: Michael A Carducci
• 金额: $ 183.64万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-13 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10784843
• 关键词: Acceleration; Biological; Biological Assay; Biological Markers; Biopsy Specimen; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Characteristics; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Comprehensive Cancer Center; Development; Discipline; Disease; Drug resistance; Educational Activities; Eligibility Determination; Environment; Evaluation; Evolution; Fostering; Goals; Good Clinical Practice; Grant; Image; Immunologic Monitoring; Infrastructure; Institution; Intervention; Investigational Therapies; Kimmel Cancer Center at the Thomas Jefferson University; Laboratories; Laboratory Study; Lead; Leadership; Letters; Location; Malignant Neoplasms; Medical; Memorial Sloan-Kettering Cancer Center; Mentors; Methodology; Molecular; NCI-Designated Cancer Center; National Clinical Trials Network; New Agents; Organizational Affiliation; Participant; Pathologist; Pathway interactions; Patient Selection; Patients; Pharmacodynamics; Phase; Phase I Clinical Trials; Protocols documentation; Quality of Care; Research; Research Personnel; Resource Sharing; Resources; Rural; Science; Site; Statistical Data Interpretation; Team Process; Toxic effect; Training; Translating; Translational Research; Universities; University of Virginia Cancer Center; Wisconsin; assay development; biomarker development; biomarker validation; cancer clinical trial; career; clinical care; clinical development; clinical investigation; clinical translation; data sharing; design; drug development; drug sensitivity; early phase clinical trial; early phase trial; experience; innovation; interest; meetings; member; molecular subtypes; next generation; novel; novel anticancer drug; novel therapeutics; participant enrollment; patient population; radiologist; rare cancer; response; stem; success; trial design

With the evolution of the Experimental Therapeutics Clinical Trials Network (ETCTN), the Johns Hopkins Translational Science Team (JHTST) expanded in 2016 by bringing 5 (now 6) Affiliate Organizations (AO) under our Lead Academic Organization (LAO) with the goal to enhance and accelerate our collective contribution to the drug development efforts of the NCI. We have organized a comprehensive and cohesive infrastructure that can conduct high-quality clinical trials evaluating novel anticancer agents, in combinations, in molecularly selected patient populations, or rare tumor sites. Our infrastructure stems from the need to be clinically efficient, regulatory compliant and scientifically rigorous in our approach as we collaborate as network members within the ETCTN. Our infrastructure consists of seven experienced NCI-designated Cancer Centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Emory Winship Cancer Institute, Georgetown Lombardi Comprehensive Cancer Center, Sidney Kimmel Cancer Center at Thomas Jefferson University, Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, and University of Wisconsin Carbone Cancer Center. This collection of Centers brings together many unique discovery strengths, diverse patient volumes, and locations both urban and rural. We will focus on 4 Specific Aims: Aim 1- To lead and maintain a clinical trial consortium that will support cancer clinical trials from Phase 1 initiation through proof-ofactivity and foster seamless Phase 2 clinical development of NCI CTEP IND agents; Aim 2- To actively participate and engage disease-focused clinical investigators in the ETCTN by promoting accrual to a range of ETCTN studies led by other LAO/AO members; Aim 3- To incorporate and implement innovative correlative and biological laboratory studies in the context of or as eligibility for participation in early phase clinical studies that enhance our understanding of determinants of toxicity and response that will be used for further definitive practice-changing clinical trial evaluation; and Aim 4- To train the next generation of investigators in drug development. With 7 Centers within our Consortium, we anticipate no problem in meeting the grant metrics of 100 accruals per year, submitting enough LOI concepts to have 6 new studies approved each year, functioning as a network by having Disease-Focused Clinical Investigators champion ETCTN studies at each Site across disease sites, and to provide opportunities to engage and train early career investigators in drug development. We anticipate that our contributions within the ETCTN will impact the clinical care of cancer patients.

随着实验治疗临床试验网络 (ETCTN) 的发展，约翰霍普金斯大学 转化科学团队 (JHTST) 于 2016 年扩大规模，引入了 5 个（现为 6 个）附属组织 (AO) 在我们的领导学术组织（LAO）的领导下，目标是增强和加速我们的集体 为 NCI 的药物开发工作做出贡献。我们组织了一次全面而有凝聚力的 可以进行高质量临床试验的基础设施，评估新型抗癌药物的组合、 分子选择的患者群体或罕见的肿瘤部位。我们的基础设施源于需要 当我们作为网络进行合作时，我们的方法具有临床效率、合规性和科学严谨性 ETCTN 内的成员。我们的基础设施由七个经验丰富的 NCI 指定癌症中心组成： 约翰霍普金斯大学西德尼金梅尔综合癌症中心、埃默里温希普癌症研究所、乔治城 隆巴迪综合癌症中心、托马斯杰斐逊大学悉尼金梅尔癌症中心、 纪念斯隆凯特琳癌症中心、弗吉尼亚大学癌症中心和威斯康星大学 卡本癌症中心。该中心集合汇集了许多独特的发现优势、多样化的 患者数量以及城市和农村的地点。我们将重点关注 4 个具体目标： 目标 1 - 领导和 维持一个临床试验联盟，支持从 1 期启动到活动证明的癌症临床试验，并促进 NCI CTEP IND 药物的无缝 2 期临床开发；目标 2- 积极主动 通过促进一系列应计项目，参与并吸引以疾病为重点的临床研究人员参与 ETCTN 由其他 LAO/AO 成员领导的 ETCTN 研究；目标 3 - 纳入并实施创新相关措施 以及参与早期临床研究背景下或作为参与早期临床研究资格的生物实验室研究 增强我们对毒性和反应决定因素的理解，这些因素将用于进一步明确 改变实践的临床试验评估；目标 4 - 培训下一代药物研究人员 发展。我们联盟内有 7 个中心，我们预计满足以下资助指标不会有任何问题 每年 100 个应计项目，提交足够的 LOI 概念，每年批准 6 项新研究，并发挥作用 作为一个网络，让以疾病为中心的临床研究人员在每个站点支持 ETCTN 研究 疾病现场，并提供机会吸引和培训药物开发领域的早期职业研究人员。 我们预计我们在 ETCTN 中的贡献将影响癌症患者的临床护理。