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

• 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
• 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

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.

提交此申请是为了向ETCTN的附属组织（AO）申请额外资金 UM 1领导学术组织（LAO）。随着实验治疗药物临床试验的发展 网络（ETCTN），约翰霍普金斯转化科学团队（JHTST）在2016年扩大了5 (now 8与2020年的行政补充）我们的法律援助办公室下的AO，目标是加强和加快 我们共同为国家癌症研究所的药物研发做出贡献。我们组织了一次全面的 和有凝聚力的基础设施，可以进行高质量的临床试验，评估新的抗癌药物， 组合，在分子选择的患者群体中，或罕见的肿瘤部位。我们的基础设施源于 我们的方法需要临床有效、符合法规要求和科学严谨， 作为ETCTN内的网络成员进行协作。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国家癌症研究所指定的癌症中心：约翰霍普金斯西德尼 基梅尔综合癌症中心，埃默里温希普癌症研究所，乔治敦伦巴第 综合癌症中心，托马斯杰斐逊大学纪念西德尼·金梅尔癌症中心 斯隆凯特琳癌症中心，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和马里兰州格林鲍姆大学 癌症中心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4个具体目标：目标1-领导和保持一个 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;和目标4-培养下一代药物开发研究人员。 我们的联盟中有9个中心，我们预计满足100个应计项目的赠款指标没有问题 每年提交8个意向书概念，每年批准1项新研究，作为一个网络， 让以疾病为中心的临床研究者在每个研究中心支持ETCTN研究， 并提供参与和培训药物开发早期职业调查人员的机会。我们预计 我们在ETCTN内的贡献将影响癌症患者的临床护理。