ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center

ACTIV 针对 COVID-19 的宿主靶向治疗整合行政协调中心

• 批准号: 10793916
• 负责人: Tracy L Nolen
• 金额: $ 41720.15万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10793916
• 关键词: Address; Adoption; Area; Behavior Therapy; Biological Products; Biometry; Blood; Blood Vessels; COVID-19; COVID-19 intervention; COVID-19 pandemic; COVID-19 treatment; Cardiovascular system; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Communication; Complex; Consensus; Critical Care; Data Collection; Data Coordinating Center; Development; Devices; Doctor of Philosophy; Documentation; Effectiveness; Ensure; Funding; Goals; Heart; Human Resources; Image; Industry; Informatics; Information Dissemination; Infrastructure; International; Knowledge; Lead; Leadership; Lung; Medical; Medicine; National Heart, Lung, and Blood Institute; North Carolina; Online Systems; Operative Surgical Procedures; Outcome; Pharmaceutical Preparations; Phase; Principal Investigator; Process; Qualifying; Ramp; Reporting; Research; Research Design; Resources; Role; Running; Scientist; Site; Speed; Standardization; Statistical Data Interpretation; Technology; Therapeutic; Time; United States National Institutes of Health; Universities; Validation; clinical practice; clinical research site; data harmonization; data quality; data standards; design; experience; flexibility; informatics tool; insight; knowledge base; knowledgebase; operation; professor; programs; protocol development; sound; targeted treatment; therapy development

RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHand industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.

RTI International很高兴按照研究机会提供此申请 公告OTA-20-011宿主靶向疗法的激活疗法为COVID-19的角色 行政协调中心（ACC）。我们应用的标题是激活集成的 COVID-19的宿主靶向疗法。 COVID-19计划的宿主目标疗法的整合旨在识别Covid-19 与心脏，肺，血液和心血管结局有关的干预措施，导致科学 知识库可能会为临床实践提供依据。该计划将迅速有效地进行 通过数据协调中心和临床站点的协调努力进行自适应平台试验 现有的临床研究网络。 ACC是程序的关键组成部分。我们将协调 与NHLBI一起确保网络之间的协作，包括在 临床试验设计和行为，数据收集和验证以及统计分析，以便研究 迅速启动，实施和分析；研究结果在科学上是合理的，满足 医疗疗法开发的监管需求。作为ACC，我们还将发挥至关重要的作用 促进所有相关利益持有人之间的沟通和信息共享并帮助NHLBI 在跟踪特定于学习和程序范围的里程碑中。 DRPH的Sonia Thomas将领导ACC担任首席研究员。她是经验丰富的CC PI， 统计学家在多中心Nihand的设计，实施和分析方面拥有25年的经验 由行业赞助的2-4期药物，生物制剂，设备，手术和行为的临床试验 多十个治疗迹象的干预措施。托马斯博士将得到特雷西的支持 诺伦（Nolen），drph作为备用PI，经验丰富的财团和CC PI和临床统计学家，以及 主题专家史蒂夫·尼森（Steve Nissen），医学博士，克利夫兰临床首席学术官，心脏和 血管研究所，医学博士香农·卡森（Shannon Carson），大学。北卡罗来纳州肺部和重症监护官 医学和Anastasia Ivanova博士，大学。北卡罗来纳州生物统计学教授 在托马斯博士的指导下，我们的团队将领导，支持和与计划网络合作 通过组织成6个ACC核心：计划运营，科学领导和 优先级，信息学，数据标准，研究设计，实施和分析以及 监管和质量检查。我们已经确定了每一个中ACC的基本活动的里程碑 这6个核心详细关注了头六个月的活动，随着活动的完成 这次对于确保该计划的协调，加快和高效的启动最为重要。 托马斯博士，我们的主题专家，高级统计科学家和许多核心领导者 在NHLBI方面有丰富的经验，因此了解研究所的需求和优先事项 利用这些知识更好地与NHLBI合作，并进一步加快该程序的启动。 作为总体Trans-NIH活动的一部分，我们愿意与所有相关实体合作 随着演变的发展。我们认识并期望需要快速改编才能快速适应 应对紧急临床研究需要解决COVID-19-19的大流行。 RTI具有唯一和实质性的ACC资格。我们将利用团队的广泛经验 许多复杂的协调中心项目，以预测该计划的需求，并“打击 运行”。现有NIH程序正在使用的经过验证的信息技术将迅速修改 我们的分析师快速部署通信平台。我们的组织规模和灵活性 将使我们能够快速提高并灵活修改人事资源。最后，RTI有一个验证的轨道 与其他协调有关复杂计划的成功合作的记录，但正如我们一样 不直接参与任何网络以供NHLBI COVID-19试验站点，我们 为该计划提供独立性和目标。