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

杜克大学-北卡罗来纳大学-华盛顿大学合作开展癌症早期临床试验

• 批准号: 8725805
• 负责人: ELIZABETH CLAIRE DEES
• 金额: $ 50.62万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-04 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8725805
• 关键词: Address; Antineoplastic Agents; Biological Markers; Blood; Brain Neoplasms; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Clinical; Clinical Trials; Collaborations; Combined Modality Therapy; Commit; Communities; Comprehensive Cancer Center; Correlative Study; Data; Data Analyses; Development; Development Plans; Disease; Drug Kinetics; Enrollment; Evaluation; Faculty; Future; Genomics; Goals; HIV; Hematologic Neoplasms; Image; Immune response; Immunologic Monitoring; Institutes; Institution; Laboratories; Letters; Malignant Neoplasms; Mentors; Mentorship; Methods; Molecular; Molecular Profiling; Multicenter Trials; Mutation; North Carolina; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacogenomics; Phase; Phase II Clinical Trials; Population; Proteomics; Protocols documentation; Records; Regimen; Research; Research Infrastructure; Research Personnel; Satellite Viruses; Science; Signal Pathway; Site; Solid Neoplasm; Structure; Sum; Testing; Therapeutic; Tissues; Training; Translating; Translations; Universities; Washington; angiogenesis; anticancer research; base; bench to bedside; cancer therapy; cancer type; career development; design; drug development; experience; improved; innovation; interest; meetings; next generation; novel; novel strategies; oncology; operation; patient population; programs; response; translational study; tumor

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.

描述（由申请人提供）：ET-CTN有望为我们的癌症管理提供突破性进展。为了让ET-CTN实现这一机会，它需要有效地解决早期药物开发中的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、华盛顿大学的Lineberger综合癌症中心和华盛顿大学的Siteman癌症中心之间建立早期肿瘤药物开发的新战略伙伴关系。杜克大学-华盛顿大学合作伙伴关系创建了一个ET-CTN网站，由三个国家的NCI指定的综合癌症中心组成，并利用他们的临床和科学专业知识来推进癌症药物的开发。这种伙伴关系提供了世界级的广度和深度，无论是临床和科学，以满足ET-CTN的目标。这一合作伙伴关系每年管理超过18，000例新的癌症病例; 2012年，这三个中心招募了3，200多名新患者参加早期临床试验，类似于ET-CTN所设想的临床试验。我们的网站既有临床专业知识，也有研究针对利基人群的新型药物所需的临床数量，我们的网站将把ET-CTN与我们巨大的基础和转化癌症研究社区联系起来，新的药物和治疗方法可能会出现。我们在多中心研究的管理和这些研究的生物标志物分析方面也有特殊的专业知识，与ET-CTN直接相关的经验。我们还在分子基因组学和蛋白质组学分析以及生物标志物开发方面拥有世界一流的专业知识。杜克大学-华盛顿大学合作伙伴关系将通过以下具体步骤帮助实现ET-CTN目标：（1）参与世界级的疾病和翻译团队，这些团队是协作和团队科学导向的;（2）开发创新的策略和方法，用于开发新型抗癌药物和联合治疗方案，并参与ET-CTN项目团队，为新方法制定药物开发计划;（3）响应NCI的癌症治疗评估计划（CTEP）的要求，有效地开发高质量的正式提案和方案;（4）有效地管理试验并迅速累积到所有ET-CTN试验中;以及（5）将从试验和相关研究中获得的信息从实验室到床边和床边到实验室翻译;以及（6）指导肿瘤药物开发方面的新研究者和研究员。为了与我们的临床和科学优势相匹配，将特别强调针对特定遗传改变，改变信号通路，宿主免疫反应，血管生成和其他基质反应的新型疗法和组合。