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: 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
• 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

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.

随着实验治疗药物临床试验网络（ETCTN）的发展，约翰霍普金斯 翻译科学团队（JHTST）在2019年扩大，将8个附属组织（AO）纳入我们的 领导学术组织（LAO）的目标是加强和加速我们对全球经济的集体贡献。 NCI的药物开发工作。我们已经建立了一个全面和有凝聚力的基础设施， 进行高质量的临床试验，评估新的抗癌药物，在组合，在分子选择 患者群体或罕见肿瘤部位。我们的基础设施源于临床效率的需要， 我们的方法符合法规要求，科学严谨，因为我们作为网络成员在 的ETCTN。在提交这份行政补充文件后，我们的基础设施将包括9个 经验丰富的NCI指定癌症中心：约翰霍普金斯西德尼金梅尔综合癌症中心， 埃默里温希普癌症研究所，乔治敦隆巴迪综合癌症中心，纪念斯隆 凯特林癌症中心，弗吉尼亚大学癌症中心，威斯康星州大学Carbone癌症 中心，科罗拉多大学综合癌症中心，马里兰州格林鲍姆大学 癌症中心和维克森林浸信会综合癌症中心（这是最新的和重点 补充）。这些中心汇集了许多独特的发现优势， 城市和农村的数量和地点。我们将专注于5个具体目标：目标1-领导和维持一个 临床试验联盟，将支持从1期启动到活性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-积极参与并 通过促进一系列ETCTN研究的累积，在ETCTN中吸引以疾病为重点的临床研究者 目标3-纳入和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， 我们对毒性和反应决定因素的理解将用于进一步的确定性实践- 改变临床试验评估;目标4-培训下一代药物开发研究人员;以及 目标5-促进ETCTN试验中服务不足/少数民族参与者的多样性和包容性。9个中心 在我们的联盟中，我们预计在满足每年100个应计项目的赠款指标方面没有什么问题， 每年最多提交8个意向书概念，每年至少批准2项新研究， 通过让疾病为重点的临床研究者在每个研究中心支持ETCTN研究， 疾病的网站，并提供机会，从事和培训早期职业研究人员在药物开发。 我们预计，我们在ETCTN内的贡献将影响癌症患者的临床护理。