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: 10171728
• 负责人: Tracy L Nolen
• 金额: $ 6817.78万
• 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/10171728
• 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 International 很高兴根据研究机会的要求提供此申请 公告 OTA-20-011 ACTIV 针对 COVID-19 的宿主靶向疗法的整合 行政协调中心（ACC）。我们的应用程序的标题是 ACTIV Integration of COVID-19 行政协调中心的宿主靶向治疗。 COVID-19 宿主靶向治疗整合计划旨在识别 COVID-19 与心脏、肺、血液和心血管结果相关的干预措施有助于科学 知识库可能为临床实践提供信息。该计划将快速有效地进行 通过数据协调中心和临床中心的协调努力进行适应性平台试验 现有的临床研究网络。 ACC 是该计划的重要组成部分。我们将协调 与 NHLBI 合作，确保网络之间的协作，包括在 临床试验设计和实施、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；研究结果科学合理，符合 药物治疗开发的监管需求。作为 ACC，我们还将发挥重要作用 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 跟踪特定研究和计划范围内的里程碑。 公共卫生博士索尼娅·托马斯 (Sonia Thomas) 将作为首席研究员领导 ACC。她是一位经验丰富的 CC PI， 统计学家，在多中心 NIHand 的设计、实施和分析方面拥有 25 年经验 行业赞助的药物、生物制品、设备、手术和行为的 2-4 期临床试验 对十多种治疗适应症进行干预。托马斯博士将得到特雷西的支持 Nolen，DrPH 作为候补 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 血管研究所，香农卡森，医学博士，大学。北卡罗来纳州肺科和重症监护科主任 医学和阿纳斯塔西娅·伊万诺娃（Anastasia Ivanova）博士，大学。北卡罗来纳州生物统计学教授 在 Thomas 博士的指导下，我们的团队将领导、支持 Program Networks 并与之合作 通过组织成 6 个 ACC 核心：项目运营、科学领导和 优先顺序、信息学、数据标准、研究设计、实施和分析，以及 监管和质量保证。我们已经确定了 ACC 在各个领域的基本活动的里程碑 这 6 个核心详细关注前 6 个月内完成的活动 这对于确保该计划的协调、快速、高效启动至关重要。 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 在 NHLBI 方面拥有丰富的经验，因此了解该研究所的需求和优先事项，并将 利用这些知识更好地与 NHLBI 合作并进一步加快该计划的启动。 我们愿意与所有相关实体合作，作为跨 NIH ACTIV 总体计划的一部分 随其发展而制定计划。我们认识到并预计需要迅速适应 满足应对 COVID-19 大流行的紧急临床研究需求。 RTI 具有独特且实质上符合 ACC 资格的资格。我们将利用我们团队的丰富经验 许多复杂的协调中心项目来预测该计划的需求并“落地” 现有 NIH 项目使用的经过验证的信息学技术将被迅速修改 我们的分析师负责快速部署通信平台。我们的组织规模和灵活性 将使我们能够快速提升并灵活调整人力资源。最后，RTI 有一个经过验证的轨道 与其他协调中心就复杂项目进行成功合作的记录，但正如我们所 不直接参与任何考虑成为 NHLBI COVID-19 试验站点的网络，我们 为计划提供独立性和客观性。