Duke-UNC-Wash U Partnership for Early Phase Clinical Trials in Cancer

描述(由申请人提供)：ET-CTN准备为我们的癌症管理提供突破性进展。对于ET-CTN来说，要实现这一机会，它需要在早期药物开发中有效地驾驭许多科学和操作问题。为了应对这些挑战，我们提议在杜克癌症研究所、北卡罗来纳大学的莱恩伯格综合癌症中心和华盛顿大学的西特曼癌症中心建立新的早期肿瘤学药物开发战略伙伴关系。杜克大学-北卡罗来纳大学-华盛顿大学合作伙伴关系创建了一个ET-CTN网站，由NCI指定的三个全国综合癌症中心组成，并利用它们的临床和科学专业知识来推动癌症药物的开发。这一伙伴关系在临床和科学上提供了世界级的广度和深度，以实现ET-CTN的目标。这一合作伙伴关系加在一起，每年管理超过18,000例新的癌症病例；2012年，这三个中心招募了3,200多名新患者参加与ET-CTN设想的类似的早期临床试验。我们的网站拥有针对利基人群的新型药物研究所需的临床专业知识和临床容量，我们的网站将把ET-CTN连接到我们庞大的基础和转化型癌症研究社区，从那里可能会出现新的药物和治疗方法。我们还在多中心研究的管理和这些研究的生物标记物分析方面拥有特殊的专业知识，这些经验与ET-CTN直接相关。我们还带来了世界一流的分子基因组和蛋白质组谱分析以及生物标记物开发方面的专业知识。杜克大学-北卡罗来纳大学-华盛顿大学的伙伴关系将通过以下具体步骤帮助实现ET-CTN的目标：(1)吸引世界级的疾病和翻译团队合作，并以团队科学为导向；(2)为开发新型抗癌药物和联合疗法开发创新战略和方法，并参与ET-CTN项目团队，为新方法生成药物开发计划；(3)响应NCI癌症治疗评估计划(CTEP)的要求，高效地开发高质量的正式提案和方案；(4)有效管理试验，并迅速积累到所有ET-CTN试验；(5)翻译从试验和相关研究中获得的信息，包括床到床和床到床；以及(6)指导肿瘤药物开发方面的新研究人员和研究员。为了与我们的临床和科学优势相匹配，我们将特别强调针对特定基因改变、改变的信号通路、宿主免疫反应以及血管生成和其他间质反应的新疗法和组合。 相关性：杜克大学-北卡罗来纳大学-华盛顿大学伙伴关系致力于并非常适合实现ET-CTN的目标，即迅速将新科学转化为更有效的癌症治疗方法

DESCRIPTION (provided by applicant): The ET-CTN is poised to provide break-through advances in our management of cancer. For the ET-CTN to realize this opportunity, it needs to effectively navigate many scientific and operational issues in early phase drug development. To address these challenges, we propose a new strategic partnership in early oncology drug development across the Duke Cancer Institute, the Lineberger Comprehensive Cancer Center at UNC, and the Siteman Cancer Center at Washington University. The Duke-UNC-Wash U Partnership creates an ET-CTN site composed of three of the nation's NCI-designated Comprehensive Cancer Centers and leverages their combined clinical and scientific expertise to advance drug development in cancer. This Partnership provides world class breadth and depth, both clinically and scientifically, to meet the goals of the ET-CTN. Combined, this partnership manages over 18,000 new cancer cases per year; in 2012, the three centers enrolled more than 3,200 new patients onto early phase clinical trials similar to the ones envisioned by the ET-CTN. Our site has both the clinical expertise and the clinical volumes needed for the study of novel agents targeting niche populations, and our site will connect the ET-CTN to our tremendous basic and translational cancer research communities from which new drugs and therapeutic approaches are likely to emerge. We also have particular expertise in the management of multi-center studies and the analysis of biomarkers on these studies, experience directly relevant to the ET-CTN. We also bring world class expertise in molecular genomic and proteomic profiling and biomarker development. The Duke-UNC-Wash U Partnership will help achieve ET-CTN goals through the following specific steps; (1) engaging world class disease and translational teams that are collaborative and team-science oriented; (2) developing innovative strategies and approaches for development of novel anti-cancer agents and combination regimens and participating in ET-CTN project teams to generate drug development plans for novel approaches; (3) efficiently developing high-quality formal proposals and protocols in response to requests from the NCI's Cancer Therapy Evaluation Program (CTEP); (4) effectively managing trials and accruing rapidly to all ET-CTN trials; and (5) translating information gained from the trials and correlative studies, both bench-to-bedside and bedside-to-bench; and (6) mentoring new investigators and fellows in oncology drug development. To match our clinical and scientific strengths, particular emphasis will be placed upon novel therapies and combinations that target specific genetic alterations, altered signaling pathways, host immune responses, and angiogenesis and other stromal responses. RELEVANCE: The Duke-UNC-Wash U Partnership is committed and ideally suited to realizing the goals of the ET-CTN to rapidly translate novel science into more effective cancer therapies