ViKTriY Early Clinical Trials Consortium (ECTC)

描述（由申请人提供）：早期临床试验的结果是构建2期和3期工作的基石，并在此基础上推导与药物作用生物学基础相关的科学推断。这个药物开发的新时代——一个分子靶向治疗的时代——代表了一种范式的转变，即早期研究相对于“传统”治疗方法而言，不考虑潜在的肿瘤基因组学、生物学和免疫学。翻译终点，包括靶表达水平、参与和下游效应物的调节，正在尽可能早地进行评估，并且越来越重视早期患者选择，利用新的生物标志物测定和分子表征来确定最有可能应答的患者。NCI实验治疗-临床试验网络（ET-CTN）的最终目的是为开发新型抗癌药物确定更好的方法，利用肿瘤分子特征的能力，找到合适的生物标志物，选择最有可能对特定药物产生反应的患者。ET-CTN的目标不可能由任何一个研究者或机构来实现，它需要具有互补专业知识的合作、多样化和忠诚的成员。为了整合所需的协同专业知识以协助ET-CTN实现其目标，我们已经组建了一个综合团队，在这个药物开发的新时代进行临床和转化研究。该团队的目标是：1)对新型抗癌药物及其组合进行严格控制的早期临床试验；2)招募至少12%的服务不足/特殊人群；3)研究新型药物的临床药理学、药代动力学、药效学和药物基因组学，并在适当的情况下结合非侵入性成像工具；4)利用生物标志物检测和先进的分子表征工具来识别与治疗反应和耐药性相关的分子因素。该团队的成员在合作研究和指导下一代癌症研究人员方面具有独特的互补专业知识和相似的理念。这一合作关系被称为范德比尔特-格兰姆、卡尔马诺斯、TGen研究所、耶鲁大学-早期癌症治疗联盟（ViKTriY - ECTC）。这个ViKTriY团队致力于利用他们的专业领域，最大限度地发挥他们的合作关系，以改善癌症患者的预后为最终使命。

DESCRIPTION (provided by applicant): Results from early phase clinical trials have been the cornerstone upon which Phase 2 and 3 efforts are constructed, and upon which scientific inference relative to the biological basis for drug action is imputed. This new era in drug development-an era of molecularly targeted treatments-represents a paradigm shift in how early phase studies are considered relative to the "conventional" approach of treating without consideration to underlying tumor genomics, biology and immunology. Translational endpoints, including levels of target expression, engagement, and modulation of downstream effectors are being assessed as early as possible, and increasing emphasis is being placed on early patient selection, utilizing novel biomarker assays and molecular characterization to identify patients most likely to respond. The ultimate purpose of the NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN) is to define better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and find appropriate biomarkers to select patients most likely to respond to specific agents. The goals of the ET-CTN cannot be achieved by any single investigator or institution and will require collaborative, diverse, and committed members with complementary expertise. To assemble the synergistic expertise required to assist ET-CTN in reaching its goals, a comprehensive team has been formed to perform clinical and translational research in this new era of drug development. This team aims to 1) conduct carefully-controlled early clinical trials of novel anticancer agents and combinations; 2) recruit at least 12% underserved/special populations; 3) study the clinical pharmacology, pharmacokinetics, pharmacodynamics, and pharmacogenomics of novel agents, and where appropriate, incorporate noninvasive imaging tools; and 4) utilize biomarker assays and advanced molecular characterization tools to identify molecular factors associated with treatment response and resistance. The members of this team have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. This partnership has been termed the Vanderbilt-lngram, Karmanos, TGen Research Institute, Yale - Early Cancer Therapeutics Consortium (ViKTriY - ECTC). This ViKTriY team is committed to utilizing their areas of expertise and maximizing their collaborative relationships with the ultimate mission of improving outcomes for patients with cancer.