Experimental Therapeutics: Clinical Trials Network with Phase I Emphasis

描述(由申请人提供)：芝加哥医科大学(UC)建议加入早期治疗-临床试验网络(ET-CTN)。新型抗癌药物的早期开发需要创新的方法来适应不断变化的癌症治疗发展环境。晚期转移性实体肿瘤的护理标准有所提高，分子生物技术的快速技术进步带来了新的工具和治疗策略，信息技术的进步使收集和分析更大的数据集以及更有效的机构间合作成为可能。但基本原则是 药物开发仍然是改善癌症护理的关键。我们的中心建议加入ET-CTN，作为一个高度合作的网站，在团队科学方面经验丰富，在以下方面拥有特定的专业知识：创新的临床试验设计和定量分析方法，生物标记物在早期治疗开发中的应用和验证，以及癌症治疗的药物基因组学。我们的网站提供了综合癌症中心的资源和专业知识，这是一支拥有丰富经验的早期治疗开发团队，以及一支拥有特定疾病患者护理和研究专业知识的临床肿瘤学家团队。我们的领导层已经在NCI研究药物指导委员会和合作小组以及NIGMS赞助的药物基因组学研究网络中开展了有效的团队科学。UC团队成员将积极参与由网络中的协作小组领导的项目，提供他们相关的专业知识。加州大学将领导药物基因组学、生物标记物验证以及设计和进行新的临床试验的努力。我们还计划实施计算建模和模拟策略，以：1)改进试验设计，2)确定在以后的试验中要测试的新药物的剂量范围，3)证明候选生物标记物与进一步开发的相关性，以及4)支持ET-CTN关于哪些药物和组合最可能对药物开发的后期阶段的临床护理产生预期影响的战略决策。 相关性：这笔赠款将支持芝加哥大学的一个由医学肿瘤学家、药理学家、护士、病理学家和实验室科学家组成的团队的共同努力，他们将与一个由类似研究人员组成的全国网络合作，对新的实验性抗癌药物进行早期测试。这个高度互动的团队将帮助国家癌症研究所加快向癌症患者提供更安全、更有效的治疗。

DESCRIPTION (provided by applicant): The University of Chicago Medicine (UC) proposes to join the Early Therapeutics-Clinical Trials Network (ET-CTN). The early development of novel anticancer agents requires innovative approaches to adapt to the changing environment of cancer therapeutics development. Standards of care for advanced metastatic solid tumors have improved, rapid technological advances in molecular biotechnology have brought new tools and therapeutic strategies, and advances in information technology enable collection and analysis of larger datasets and more efficient inter-institutional collaboration. But fundamental principles of drug development remain essential to improving cancer care. Our center proposes to join the ET-CTN as a highly collaborative site, experienced in team science, with specific expertise in: innovative clinical trial design and quantitative analysis methods, application and validation of biomarkers in early therapeutics development, and pharmacogenomics of cancer therapeutics. Our site brings the resources and expertise of our Comprehensive Cancer Center, an early therapeutics development team with extensive experience, and a team of clinical oncologists with both disease-specific patient care and research expertise. Our leadership have already conducted effective team science within the NCI Investigational Drug Steering Committee and Cooperative Groups as well as in the NIGMS-sponsored Pharmacogenomics Research Network. UC team members will participate actively on projects led by the collaborative groups in the network, offering their relevant expertise. UC will lead efforts in pharmacogenomics, biomarker validation, and design and conduct of novel clinical trials. We also plan to implement computational modeling and simulation strategies to: 1) improve trial designs, 2) identify the range of doses of new agents to be tested in later trials, 3) to demonstrate relevance of candidate biomarkers for further development, and 4) support strategic decision-making by the ET-CTN on which agents and combinations are most likely to have the intended impact on clinical care in later phases of drug development. RELEVANCE: This grant will support the joint efforts of a team of medical oncologists, pharmacologists, nurses, pathologists, and laboratory scientists from the University of Chicago who will work with a national network of similar researchers to conduct the early phase testing of new experimental anticancer drugs. This highly interactive team will help the National Cancer Institute to expedite the delivery of safer, more effective treatments to cancer patients.