The Johns Hopkins Translational Science Team for the ET-CTN

约翰·霍普金斯大学 ET-CTN 转化科学团队

基本信息

批准号：
10393294
负责人：
Michael A Carducci
金额：
$ 9.98万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-01 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10393294
关键词：
Administrative Supplement 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 Development Discipline Disease Drug resistance Early Therapeutic-Clinical Trials Network Educational Activities Eligibility Determination Enrollment Environment Evaluation Evolution Fostering Funding Goals Good Clinical Practice Grant Image Immunologic Monitoring Infrastructure Institutes Institution Intervention Investigational Therapies Kimmel Cancer Center at the Thomas Jefferson University Laboratories Laboratory Study Lead Leadership Letters Location Malignant Neoplasms Maryland Medical Memorial Sloan-Kettering Cancer Center Mentors Methodology Molecular NCI-Designated Cancer Center National Clinical Trials Network New Agents Participant Pathologist Pathway interactions 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 cohesion 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 patient population radiologist rare cancer response stem success trial design

项目摘要

This application is being submitted to request additional funds for Affiliated Organizations (AO) to an ETCTN UM1 Lead Academic Organization (LAO). 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 8 with the 2020 administrative supplement) AO under our 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, Sidney Kimmel Cancer Center at Thomas Jefferson University, Memorial Sloan Kettering Cancer Center, University of Virginia Cancer Center, University of Wisconsin Carbone Cancer Center, University of Colorado Comprehensive Cancer Center, and The University of Maryland Greenebaum 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-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; and Aim 4- To train the next generation of investigators in drug development. With 9 Centers within our Consortium, we anticipate no problem in meeting the grant metrics of 100 accruals per year, submitting 8 LOI concepts to have 1 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.

该申请被提交向eTCTN要求附属组织（AO）要求其他资金 UM1领导学术组织（LAO）。随着实验疗法临床试验的发展网络（ETCTN），约翰·霍普金斯转化科学团队（JHTST）在2016年扩大了5个（现在有2020年的行政补充）在我们老挝的AO中，其目标是增强和加速我们对NCI药物开发工作的集体贡献。我们已经组织了一个全面的以及可以进行高质量临床试验评估新型抗癌药的凝聚力基础设施，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在我们的方法中，需要在我们的方法中保持临床高效，符合法规规定和科学严格作为ETCTN中的网络成员合作。在此行政补充的提交中，我们的现在，基础设施将由9个经验丰富的NCI指定的癌症中心组成：Johns Hopkins Sidney 金梅尔综合癌症中心，乔治敦·伦巴第纪念馆托马斯·杰斐逊大学西德尼·金梅尔癌症中心综合癌症中心弗吉尼亚大学癌症中心，威斯康星大学癌癌症中心斯隆·凯特林癌症中心科罗拉多大学综合癌症中心和马里兰大学格林鲍姆大学中心癌症中心。这些中心的集合汇集了许多独特的发现优势，多样的患者城市和农村地区的批量和地点。我们将重点关注4个具体目标：目标1-领导和维护临床试验财团将通过活动证明支持从1阶段开始的癌症临床试验并促进NCI CTEP IND剂的无缝2阶段临床发展；目标2-积极参与并通过促进一系列ETCTN研究，参与ETCTN中以疾病为中心的临床研究者由其他老挝/AO成员领导；目标3-以合并和实施创新的相关性和生物学实验室研究以或有资格参加早期临床研究的参与资格我们对将用于进一步确定实践的毒性和反应决定因素的理解 - 改变临床试验评估；并瞄准4-培训下一代药物开发研究人员。在我们的财团内有9个中心，我们预计满足100个应计的赠款指标没有问题每年，提交8个LOI概念每年都有1个新研究，并由以疾病为中心的临床研究者在疾病部位倡导每个部位的ETCTN研究，并提供机会参与和培训早期职业调查人员进行药物开发。我们期待我们在ETCTN中的贡献将影响癌症患者的临床护理。