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.

随着实验治疗学临床试验网络（ETCTN）的演变，约翰·霍普金斯（Johns Hopkins）翻译科学团队（JHTST）在2019年扩大了我们的8个会员组织（AO）领导学术组织（LAO）的目标是增强和加速我们对集体的贡献 NCI的药物开发工作。我们已经组织了一个全面和凝聚力的基础设施进行高质量的临床试验，以分子选择的组合评估新型抗癌药患者人群或罕见的肿瘤部位。我们的基础设施源于需要在临床上有效的效率，当我们作为网络成员合作时，我们的方法符合法规规定和科学严格 etctn。在此行政补充的提交中，我们的基础设施现在将包括九个经验丰富的NCI指定的癌症中心：Johns Hopkins Sidney Kimmel综合癌症中心，乔治敦伦巴第伦巴第综合癌症中心的Emory Winship Cancer Institute，纪念Sloan 威斯康星大学弗吉尼亚大学癌症中心的Kettering Cancer Center 马里兰州格林巴姆大学科罗拉多大学综合癌症中心中心癌症中心和Wake Forest Baptist综合癌症中心（这是最新和重点补充）。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5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；目标4-培训下一代药物开发研究人员；和目的5-旨在促进多样性和在ETCTN试验中纳入服务不足/少数群体的参与者。有9个中心在我们的财团内，我们预计每年满足100份应计赠款指标的问题，每年最多提交8个LOI概念，每年至少有2项新研究批准，作为一个通过以疾病为中心的临床研究者在每个站点进行ETCTN研究通过网络疾病部位，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。