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 活动公私合作伙伴关系优先考虑，设计和协调五个自适应大师 活动临床试验的协议，并选择了许多NIH支持的网络来启动这些临床 试验以测试优先的治疗候选者。主协议允许对 多种研究剂可用，但是在相同的临床试验结构中 多个研究地点。自适应方案迅速清除未证明的实验药物 有效并确定那些做的事物。自适应主协议降低了行政负担和成本， 提供一个灵活的框架来快速识别有效的药物，并迅速移动其他实验 代理商参加试验。 Activ-1主协议正在评估至少三个免疫调节剂的安全性和功效（最初 当作为护理标准的附加疗法时，英夫利昔单抗，阿atacept和Cencicrivoroc当前 包括remdesivir，将对疾病的严重程度，恢复速度， 死亡率和医院资源利用率。 Dyderly博士是Activ-1和Activ-1和 这种补充的目的是为他和他的行政协调员提供资金支持。在他的 角色，他将与Activ和NCAT领导和领导者一起参加常规电话会议 每周协议团队与当地PI的定期呼叫。他将审查所有安全活动和其他研究 终点并向DSMB提供定期报告。他还将协调结果的报告 研究手稿的写作。