WASHINGTON UNIVERSITY INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES

华盛顿大学临床与转化科学研究所

• 批准号: 10321102
• 负责人: William G. Powderly
• 金额: $ 6.77万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-19 至 2022-03-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10321102
• 关键词: Clinical Sciences; Clinical Trials; Effectiveness; Evaluation; Event; Funding; Hospitals; Immunomodulators; Institutes; Investigation; Leadership; Manuscripts; Pharmaceutical Preparations; Powder dose form; Principal Investigator; Protocols documentation; Recovery; Reporting; Resources; Role; Safety; Severity of illness; Site; Speed; Structure; Testing; Translational Research; United States National Institutes of Health; Universities; Washington; Work; Writing; cost; design; flexibility; infliximab; mortality; public-private partnership; remdesivir; standard of care; support network; symposium; therapeutic candidate

PROJECT SUMMARY/ABSTRACT The ACTIV public-private partnership has prioritized, designed, and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. Master protocols allow coordinated and efficient evaluation of multiple investigational agents as they become available, but within the same clinical trial structure, across multiple study sites. Adaptive protocols swiftly weed out experimental drugs that do not demonstrate effectiveness and identify those that do. Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to rapidly identify drugs that work, and rapidly move additional experimental agents into the trial. The ACTIV-1 master protocol is evaluating the safety and efficacy of at least three immune modulators (initially infliximab, abatacept and cencicrivoroc when given as an add-on therapy to standard of care, which currently includes remdesivir, The different treatments will be assessed with respect to illness severity, recovery speed, mortality and hospital resource utilization. Dr. Powderly is the Principal investigator for ACTIV-1 and the purpose of this supplement is to provide funding support for him and his Administrative Coordinator. In his role, he will participate in regular conference calls with ACTIV and NCATS leadership as well as leading weekly protocol team calls and regular calls with local PIs. He will review all safety events and other study end-points and present regular reports to the DSMB. He will also coordinate the reporting of the results and the writing of study manuscripts.

项目摘要/摘要 积极公私伙伴关系优先考虑、设计和协调了五个适应性大师 Active临床试验的协议，并选择了许多由NIH支持的网络来启动这些临床试验 测试优先治疗候选药物的试验。主协议允许协调和高效地评估 多个研究药物，但在相同的临床试验结构内， 多个研究地点。适应性方案迅速淘汰了不能证明 有效性，并找出那些有效的。自适应主协议降低了管理负担和成本， 提供灵活的框架，以快速识别有效的药物，并快速移动更多的实验药物 探员进入庭审。 ACTV-1主方案正在评估至少三种免疫调节剂的安全性和有效性(最初 英夫利昔单抗、abatacept和cencicrivoroc作为标准治疗的补充治疗，目前 包括瑞希韦在内，不同的治疗方法将根据病情严重性、恢复速度、 死亡率和医院资源利用。鲍德利博士是ACTV-1的首席研究员， 本补编的目的是为他和他的行政协调员提供资金支助。在他的 ，他将与ACTV和NCATS的领导以及领导一起参加定期电话会议 每周的礼仪团队电话和与当地PI的定期电话联系。他将审查所有安全事件和其他研究 并向dsmb提交定期报告。他还将协调结果的报告和 学习文稿的写作。