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

RTI International is pleased to provide this application as requested by the Research OpportunitiesAnnouncement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the roleof Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration ofHost-targeting Therapies for COVID-19 Administrative Coordinating Center.The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientificknowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conductadaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites fromexisting Clinical Study Networks. The ACC is a critical component of the Program. We will coordinatewith NHLBI to ensure collaboration among networks including the use of standardized approaches inclinical trial design and conduct, data collection and validation, and statistical analysis such that studiesare launched, implemented and analyzed swiftly; and study findings are scientifically sound and meetregulatory needs for medical therapy development. As the ACC, we will also serve the vital role offacilitating communication and information sharing among all relevant stake holders and helping NHLBIin tracking study-specific and Program-wide milestones.Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI andstatistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHandindustry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioralinterventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by TracyNolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, andsubject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart andVascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical CareMedicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of BiostatisticsUnder Dr Thomas's direction, our team will lead, support, and collaborate with Program Networksthrough organization into 6 ACC Cores: Program Operations, Scientific Leadership andPrioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, andRegulatory and QA. We have identified milestones for the essential activities of the ACC within each ofthese 6 Cores with a detailed focus on the activities in the first 6 months as activities completed duringthis 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 havesubstantial experience with NHLBI and thus understand the needs and priorities of the Institute and willuse 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 ACTIVProgram as it evolves. We recognize and anticipate that swift adaptation will be required to rapidlyrespond 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 frommany complex coordinating center projects to anticipate the needs for this Program and "hit the groundrunning". Proven informatics technology in use by existing NIH programs will be swiftly modified byour analysts for speedy deployment of communications platforms. Our organizational size and flexibilitywill allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven trackrecord of successful collaborations with other coordinating centers on complex programs, yet as we arenot directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, weprovide independence and objectivity to the Program.