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：
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
项目类别：
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

项目摘要

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.

随着实验治疗学临床试验网络（ETCTN）的演变，约翰·霍普金斯（Johns Hopkins）转化科学团队（JHTST）在2016年扩大了5（现为6）会员组织（AO）在我们的领导学术组织（LAO）的领导下，目的是增强和加速我们的集体对NCI的药物开发工作的贡献。我们组织了一个全面而凝聚力的可以进行高质量临床试验的基础设施，以评估新型抗癌药的组合，分子选择的患者人群或罕见的肿瘤部位。我们的基础设施源于需要当我们作为网络协作时 ETCTN中的成员。我们的基础设施由七个经验丰富的NCI指定的癌症中心组成：约翰·霍普金斯·西德尼·金梅尔综合癌症中心，乔治敦Emory Winship Cancer Institute 伦巴第综合癌症中心，托马斯·杰斐逊大学西德尼·金梅尔癌症中心，纪念斯隆·凯特林癌症中心，弗吉尼亚大学癌症中心和威斯康星大学卡宾癌中心。这个集中的集合汇集了许多独特的发现优势，多样患者量以及城市和农村地区的位置。我们将专注于4个具体目标：目标1-领导和维护一个临床试验联盟，该联盟将通过活动证明并促进NCI CTEP IND剂的临床开发，从而支持1阶段开始的癌症临床试验；瞄准2-积极通过促进一系列范围来参与ETCTN并参与以疾病为中心的临床研究者 ETCTN研究由其他老挝/AO成员领导；目标3-以合并和实施创新的相关性以及在参与早期临床研究的背景下的生物实验室研究这增强了我们对毒性和反应决定因素的理解，这些决定因素将用于进一步确定性练习改变临床试验评估；目标4-培训下一代毒品调查员发展。在我们的财团内有7个中心，我们预计满足赠款指标没有问题每年100次应计，提交足够的LOI概念以每年批准6项新研究，运作作为一个以疾病为中心的临床研究者在每个地点进行ETCTN的研究，作为网络疾病部位，并提供机会参与和培训早期职业调查人员进行药物开发。我们预计我们在ETCTN中的贡献将影响癌症患者的临床护理。