The Johns Hopkins Translational Science Team for the ET-CTN

此申请是为了向ETCTN申请附属组织(AO)的额外资金 UM1领导学术组织(LAO)。随着实验治疗学临床试验的发展 网络(ETCTN)，约翰霍普金斯大学翻译科学团队(JHTST)在2016年扩大了5个 (现含2020年行政副刊8)在我们的劳资关系办公室下的行政主任，目标是加强和加快 我们为NCI的药物开发工作所做的集体贡献。我们组织了一次全面的 和凝聚力强的基础设施，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 我们的方法需要在临床上高效、遵守法规并在科学上严格，因为我们 作为ETCTN内的网络成员进行协作。随着这份行政副刊的提交，我们的 基础设施现在将由九个经验丰富的NCI指定的癌症中心组成：约翰·霍普金斯大学西德尼 坎摩尔综合癌症中心，埃默里·温希普癌症研究所，乔治敦·隆巴迪 托马斯·杰斐逊大学西德尼·基梅尔癌症中心综合癌症中心，纪念馆 斯隆·凯特林癌症中心，弗吉尼亚大学癌症中心，威斯康星大学碳骨癌 科罗拉多大学综合癌症中心和马里兰大学格林鲍姆大学 癌症中心。这个中心集合了许多独特的发现优势，不同的患者 数量，以及城市和农村的位置。我们将重点关注4个具体目标：目标1-领导和保持 临床试验联盟，将支持从第一阶段开始到活性证明的癌症临床试验 并促进NCI CTEP IND药物的无缝二期临床开发；目标2-积极参与和 通过促进一系列ETCTN研究的收益，在ETCTN中吸引专注于疾病的临床研究人员 由老挝办事处/区域组织其他成员牵头；目标3--纳入和实施创新的相关和生物 在早期临床研究的背景下进行的实验室研究或作为参与早期临床研究的资格 我们对毒性和反应的决定因素的理解将用于进一步的最终实践- 改变临床试验评估；以及目标4--培训药物开发方面的下一代研究人员。 在我们的财团中有9个中心，我们预计在满足100个应计项目的赠款指标方面没有问题 每年提交8个意向书概念，每年批准1项新研究，通过 让专注于疾病的临床研究人员在每个疾病地点支持ETCTN研究， 并提供机会，让早期职业研究人员参与和培训药物开发。我们期待着 我们在ETCTN中的贡献将影响癌症患者的临床护理。

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.