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

基本信息

批准号：
10677365
负责人：
Michael A Carducci
金额：
$ 40万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10677365
关键词：
Administrative Supplement Baptist Church Biological Biological Assay Biological Markers Biopsy Specimen Cancer Center Cancer Patient Cancer Therapy Evaluation Program Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Network Collaborations Collection Colorado Comprehensive Cancer Center Discipline Disease Educational Activities Eligibility Determination Enrollment Environment Evaluation Evolution Fostering General Population Goals Good Clinical Practice Grant Image Infrastructure Institutes Institution Intervention Investigational Therapies Laboratories Laboratory Study Lead Leadership Letters Location Malignant Neoplasms Maryland Medical Memorial Sloan-Kettering Cancer Center Mentors Methodology Minority Groups Molecular Monitor NCI-Designated Cancer Center National Clinical Trials Network New Agents Participant Pathologist Pathway interactions Patients Phase Phase I Clinical Trials Population Heterogeneity Protocols documentation Quality of Care Research Research Personnel Resource Sharing Resources Rural Rural Population Safety Site Statistical Data Interpretation Team Process Toxic effect Training Translating Translational Research Underserved Population Universities University of Virginia Cancer Center Wisconsin biomarker development biomarker validation cancer clinical trial career clinical care clinical development clinical investigation cohesion data sharing design diversity and inclusion drug development early phase clinical trial early phase trial experience forest innovation interest meetings member molecular subtypes next generation novel novel anticancer drug novel therapeutics patient population radiologist rare cancer response sound stem success trial design underserved minority

项目摘要

With the evolution of the Experimental Therapeutics Clinical Trials Network (ETCTN), the Johns Hopkins Translational Science Team (JHTST) expanded in 2019 by bringing 8 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. With the submission of this administrative supplement, our infrastructure will now consist of nine experienced NCI-designated Cancer Centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Emory Winship Cancer Institute, Georgetown Lombardi Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, University of Wisconsin Carbone Cancer Center, University of Colorado Comprehensive Cancer Center, The University of Maryland Greenebaum Cancer Center, and Wake Forest Baptist Comprehensive Cancer Center (the newest and focus of this supplement). This collection of Centers brings together many unique discovery strengths, diverse patient volumes, and locations both urban and rural. We will focus on 5 Specific Aims: Aim 1- To lead and maintain a clinical trial consortium that will support cancer clinical trials from Phase 1 initiation through proof-of-activity 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; Aim 4- To train the next generation of investigators in drug development; and Aim 5- To promote diversity and inclusion of underserved/minority participants on ETCTN trials. With 9 Centers within our Consortium, we anticipate little problem in meeting the grant metrics of 100 accruals per year, submitting up to 8 LOI concepts/year to have at least 2 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 2019 年扩大规模，将 8 个附属组织 (AO) 纳入我们的旗下领导学术组织 (LAO)，其目标是加强和加速我们对 NCI 的药物开发工作。我们组织了一个全面且有凝聚力的基础设施，可以进行高质量的临床试验，评估分子选择的新型抗癌药物的组合患者群体或罕见的肿瘤部位。我们的基础设施源于临床效率的需要，当我们作为网络成员进行合作时，我们的方法符合法规且科学严谨 ETCTN。随着这份行政补充文件的提交，我们的基础设施现在将包括九个经验丰富的 NCI 指定癌症中心：约翰·霍普金斯 Sidney Kimmel 综合癌症中心、埃默里温希普癌症研究所、乔治敦隆巴迪综合癌症中心、纪念斯隆管理学院凯特林癌症中心、弗吉尼亚大学癌症中心、威斯康星大学卡本癌症中心科罗拉多大学综合癌症中心马里兰大学格林鲍姆中心癌症中心和维克森林浸信会综合癌症中心（该中心最新的和焦点）补充）。这一系列中心汇集了许多独特的发现优势、多样化的患者城市和农村的数量和位置。我们将重点关注 5 个具体目标：目标 1 - 领导并维持临床试验联盟将支持从第一阶段启动到活性证明的癌症临床试验促进 NCI CTEP IND 药物的无缝 2 期临床开发；目标2-积极参与和通过促进一系列 ETCTN 研究的应计，让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；目标 3 - 纳入并实施创新的相关和生物技术在参与早期临床研究的背景下或作为参与资格的实验室研究，以增强我们对毒性和反应决定因素的理解将用于进一步的明确实践- 改变临床试验评估；目标 4- 培训下一代药物开发研究人员；和目标 5 - 促进 ETCTN 试验中服务不足/少数群体参与者的多样性和包容性。拥有9个中心在我们的联盟内，我们预计达到每年 100 笔应计补助的拨款指标不会有什么问题，每年提交最多 8 个 LOI 概念，每年至少有 2 项新研究获得批准，作为通过让以疾病为中心的临床研究人员在每个站点支持 ETCTN 研究来建立网络疾病现场，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。