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Principal Investigator: Tracy L Nolen
Organization: RESEARCH TRIANGLE INSTITUTE
Fiscal Year: 2024
Award: $289,604,000
Funding agency: National Heart Lung and Blood Institute
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.
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