ViKTriY Early Clinical Trials Consortium (ECTC)

描述(由申请人提供)：早期临床试验的结果一直是构建第二阶段和第三阶段努力的基石，并在此基础上对药物作用的生物学基础进行科学推断。药物开发的这个新时代--一个分子靶向治疗的时代--代表着一种范式的转变，即相对于不考虑潜在的肿瘤基因组学、生物学和免疫学的“传统”治疗方法，人们如何看待早期研究。翻译终点，包括靶表达水平、参与程度和下游效应器的调节，正在尽可能早地进行评估，并越来越重视早期患者选择，利用新的生物标记物分析和分子表征来识别最有可能反应的患者。NCI实验治疗-临床试验网络(ET-CTN)的最终目的是定义更好的方法来开发新的抗癌药物，这些药物利用从分子上表征肿瘤的能力，并找到适当的生物标记物来选择最有可能对特定药物有反应的患者。ET-CTN的目标不能由任何单一的调查员或机构实现，需要具有互补专业知识的合作、多样化和忠诚的成员。为了汇集协助ET-CTN实现其目标所需的协同专业知识，已经组建了一个全面的团队，在这个药物开发的新时代进行临床和翻译研究。该团队的目标是1)对新型抗癌药物及其组合进行仔细控制的早期临床试验；2)招募至少12%的未得到充分服务/特殊人群；3)研究新型抗癌药物的临床药理学、药代动力学、药效学和药物基因组学，并在适当的情况下采用非侵入性成像工具；以及4)利用生物标记物分析和先进的分子表征工具来确定与治疗反应和耐药性相关的分子因素。这个团队的成员在合作研究和指导下一代癌症研究人员方面拥有一套独特的互补专业知识和相似的理念。这种伙伴关系被称为Vanderbilt-Inngram，Karmanos，TGen研究所，耶鲁-早期癌症治疗联盟(ViKTriY-ECTC)。ViKTriY团队致力于利用他们的专业知识领域，最大化他们的合作关系，最终使命是改善癌症患者的预后。

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.