The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies

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）于2016年扩大，带来了5个（现在是6个）附属组织（AO） 在我们的领导学术组织（LAO）的目标是加强和加快我们的集体 为NCI的药物开发工作做出贡献。我们组织了一个全面而有凝聚力的 基础设施，可以进行高质量的临床试验，评估新的抗癌药物，在组合， 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 我们的方法具有临床效率、符合法规要求和科学严谨性， 在ETCTN的成员。我们的基础设施包括七个经验丰富的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 伦巴第综合癌症中心，托马斯杰斐逊大学西德尼·基梅尔癌症中心， 纪念斯隆凯特琳癌症中心、弗吉尼亚大学癌症中心和威斯康星州大学 Carbone癌症中心这些中心汇集了许多独特的发现优势， 患者数量和城市和农村的位置。我们将专注于4个具体目标：目标1-领导和 维持一个临床试验联盟，支持从第1期开始到证明的癌症临床试验。活动和促进NCI CTEP IND药物的无缝2期临床开发;目的2-积极 通过促进一系列以疾病为重点的临床研究者参与ETCTN， 由老挝/AO其他成员领导的ETCTN研究;目标3-纳入和实施创新的相关 在参与早期临床研究的背景下或作为参与早期临床研究的资格的生物实验室研究 这增强了我们对毒性和反应决定因素的理解， 改变实践的临床试验评估;目标4-培养下一代药物研究人员 发展我们的联盟内有7个中心，我们预计满足以下拨款指标不会有问题 每年100个应计项目，提交足够的LOI概念，每年批准6项新研究， 作为一个网络，让以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。

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.