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

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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.