The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies

随着实验治疗学临床试验网络(ETCTN)的发展，约翰霍普金斯大学 翻译科学团队(JHTST)在2016年扩大了规模，引入了5个(现在是6个)附属组织(AO) 在我们领导的学术组织(LAO)下，目标是加强和加快我们的集体 为NCI的药物开发努力做出贡献。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，评估新的抗癌药物的组合，在 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需要 在我们作为网络进行协作时，我们的方法具有临床高效、合规和科学严谨的特点 ETCTN内的成员。我们的基础设施由七个经验丰富的NCI指定的癌症中心组成： 约翰霍普金斯大学西德尼·基梅尔综合癌症中心，艾默里·温希普癌症研究所，乔治敦 伦巴迪综合癌症中心，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大学 碳骨癌中心。这个中心集合了许多独特的发现优势，不同的 患者数量，以及城市和农村地区。我们将重点关注4个具体目标：目标1-领导和 维持一个临床试验联盟，从第一阶段开始到证明有效，支持癌症临床试验，并促进NCI CTEP Ind制剂的无缝第二阶段临床开发；目标2-积极 在ETCTN中参与并吸引以疾病为重点的临床研究人员，通过促进一系列 由老挝办事处/区域组织其他成员领导的ETCTN研究；目标3--纳入和实施创新相关 在早期临床研究的背景下或作为参加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的决定因素的理解，这些决定因素将用于进一步确定 实践-改变临床试验评估；和目标4-培训下一代药物研究人员 发展。我们的联盟中有7个中心，我们预计在满足以下赠款指标方面不会有问题 每年100个应计项目，提交足够多的意向书概念，每年批准6项新研究，发挥作用 作为一个网络，通过让专注于疾病的临床研究人员在各个地点支持ETCTN研究 此外，毒品和犯罪问题办公室还提供机会，让早期职业研究者参与和培训药物开发方面的工作。 我们预计，我们在ETCTN中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.