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: 10253975
• 负责人: Sonia M Thomas
• 金额: $ 1769.32万
• 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/10253975
• 关键词: Address; Adoption; Area; Behavior Therapy; Biological; Biometry; Blood; COVID-19; COVID-19 pandemic; 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; Institutes; International; Intervention; 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; 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; 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国际很高兴提供这个应用程序的要求，研究机会 公告OTA-20-011 ACTIV整合COVID-19宿主靶向治疗的角色 行政协调中心（ACC）。我们的应用程序的标题是ACTIV集成 2019冠状病毒病宿主靶向疗法行政协调中心。 COVID-19宿主靶向疗法整合计划旨在识别COVID-19 与心脏、肺、血液和心血管结局相关的干预措施， 知识库很可能为临床实践提供信息。该计划将迅速有效地进行 通过数据协调中心和临床研究中心的协调努力进行自适应平台试验， 现有临床研究网络。ACC是该计划的一个重要组成部分。统筹推进 与NHLBI合作，确保网络之间的合作，包括使用标准化方法， 临床试验设计和实施、数据收集和验证以及统计分析， 迅速启动、实施和分析;研究结果科学合理，符合 医疗发展的监管需求。作为行政协调会，我们还将发挥以下重要作用： 促进所有相关利益相关者之间的沟通和信息共享，并帮助NHLBI 跟踪研究特定和项目范围内的里程碑。 Sonia托马斯，DrPH，将作为主要研究者领导ACC。她是一位经验丰富的CC PI， 在多中心NIHand的设计、实施和分析方面拥有25年经验的统计学家 行业赞助的药物、生物制剂、器械、手术和行为的2-4期临床试验 在十多个治疗适应症中进行干预。托马斯医生将由特蕾西协助 Nolen，DrPH作为替代PI，经验丰富的联盟和CC PI和临床试验统计学家，以及 主题专家Steve Nissen，医学博士，克利夫兰临床首席学术官，心脏和 北卡罗来纳州大学Shannon卡森医学博士血管研究所肺部和重症监护主任 医学和Anastasia Ivanova博士，北卡罗来纳州大学生物统计学教授 在托马斯博士的指导下，我们的团队将领导、支持并与项目网络合作 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 法规和QA。我们已经确定了行政协调会在以下每一个领域内基本活动的里程碑： 这6个核心，详细侧重于前6个月的活动，因为活动是在 这一时间对于确保该计划的协调，快速和有效启动至关重要。 博士托马斯，我们的主题专家，高级统计科学家，和许多核心线索， 具有NHLBI的丰富经验，因此了解研究所的需求和优先事项，并将 利用这些知识，更好地与NHLBI合作，进一步加快该计划的启动。 我们愿意与所有相关实体合作，作为总体跨NIH ACTIV的一部分 随着程序的发展。我们认识到并预计，需要迅速适应， 应对应对COVID-19大流行的紧急临床研究需求。 RTI是唯一的和实质性的资格为ACC。我们将利用我们的团队的广泛经验， 许多复杂的协调中心项目，以预测该计划的需求，并“付诸实施 跑步”。现有NIH项目使用的生物信息学技术将迅速得到修改， 我们的分析师快速部署通信平台。组织规模和灵活性 将使我们能够迅速增加并灵活调整人力资源。最后，RTI有一个经过验证的轨道 与其他协调中心在复杂项目上成功合作的记录，但正如我们 我们没有直接参与任何网络考虑成为NHLBI COVID-19试验地点， 为该计划提供独立性和客观性。