Experimental Therapeutics: Clinical Trials Network with Phase I Emphasis

描述（由申请人提供）：芝加哥医学大学（UC）提议加入早期治疗-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。晚期转移性实体瘤的护理标准得到了改善，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和更有效的机构间合作成为可能。但是药物开发的基本原则对于改善癌症护理仍然至关重要。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，具有特定的专业知识：创新的临床试验设计和定量分析方法，生物标志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。我们的网站带来了我们的综合癌症中心的资源和专业知识，一个具有丰富经验的早期治疗开发团队，以及一个具有疾病特异性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进行了有效的团队科学。UC团队成员将积极参与网络中协作组领导的项目，提供相关专业知识。UC将领导药物基因组学，生物标志物验证以及新型临床试验的设计和实施。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测试的新药剂的剂量范围，3）证明候选生物标志物的相关性以用于进一步开发，（4）支持ET的战略决策，CTN：在药物开发的后期阶段，哪些药物和组合最有可能对临床护理产生预期影响。

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.