The Vanderbilt Institute for Clinical and Translational Research (VICTR) and RTI International, a non-profit clinical research organization based in North Carolina, have been named Administrative Coordinating Center (ACC) of a national effort to streamline the research response to life-threatening lung and heart problems caused by COVID-19.
VICTR provides comprehensive support for clinical and translational research at Vanderbilt University Medical Center (VUMC).
Supported by a one-year, $2.1-million federal grant, the ACC will ensure the efficient and effective operation of a COVID-19 Clinical Trials Platform developed by the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
The goal is to enable rapid and rigorous testing of potential treatments for the pulmonary and cardiovascular consequences of COVID-19. Depending upon the course of the pandemic, the ACC grant could be extended, VUMC officials said.
NHLBI is a key participant in a wider effort called the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Initiative. Sixteen biopharmaceutical companies, four federal health agencies and the European Medicines Agency participate in the initiative, which was launched in April by the NIH and Foundation for the NIH.
In this sense the ACC will play an important role in the ACTIV initiative, which is developing an international collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials and leveraging assets to rapidly respond to COVID-19 and to future pandemics.
“The COVID-19 Clinical Trials Platform (is) an integral component of the over-arching, trans-NIH ACTIV program,” said VICTR Director Gordon Bernard, MD, the Melinda Bass Owen Professor of Medicine in the Vanderbilt University School of Medicine and VUMC’s Executive Vice President for Research.
“The ACC will assist and support the NHLBI in identifying the most compelling and strategic scientific opportunities, and will enhance the likelihood that all funded trials are successful in achieving the scientific goals,” Bernard said. “We are very enthusiastic about this opportunity to play such a pivotal national role in developing treatments for COVID-19.”
Under the terms of the agreement, VICTR is a subcontract to RTI.
The NHLBI effort is crucial because SARS-CoV-2, the virus that causes COVID-19, not only attacks the lining of the alveoli, the tiny air sacs in the lungs, but growing evidence suggests that it triggers an inflammatory response that damages other organs, including the heart and blood vessels.
“It is therefore imperative to test not only antiviral therapies, but also host-targeting treatments (including drugs and immune-modulating biologics) that … ameliorate tissue injury, enhance reparative responses, and improve health outcomes,” according to the NHLBI.
“The overall goal is to establish an inter-connected, centrally coordinated structure with clinical centers … (to) increase the clinical trial bandwidth across the country,” the NHLBI continued.
VICTR was established in 2007 to administer a five-year $40 million Clinical and Translational Science Award (CTSA) from the National Center for Research Resources of the NIH to expedite translation of laboratory discoveries to patients in the community in partnership with Nashville’s Meharry Medical College.
Consuelo Wilkins, MD, MSCI, executive director of the Meharry-Vanderbilt Alliance and VUMC vice president for Health Equity, is co-principal investigator of the CTSA with Bernard.
Some of the innovations coming out of VICTR have had national and worldwide impact. They include:
- ResearchMatch, an online national volunteer recruitment registry that matches potential research subjects with researchers throughout the country;
- REDCap, a Web-based application for building and managing online research databases that currently serves institutional partners around the globe;
- BioVU, the world’s largest collection of DNA and other biological materials stored at a single site; and
- A drug “repurposing” program that is finding new uses for drugs already on the market.
In addition, VICTR’s Vanderbilt Coordinating Center currently supports about 70 active research projects, and enrolled about 2,000 research subjects in clinical studies this year alone.
Others involved in the ACC include:
- Terri Edwards, RN, director, VUMC Research Support Services;
- Paul Harris, PhD, director of the Office of Research Informatics and professor of Biomedical Informatics, Biostatistics and Biomedical Engineering;
- Chris Lindsell, PhD, professor of Biostatistics and co-director of the HEAlth Data Science Center;
- Jana Shirey-Rice, PhD, VICTR team lead;
- Todd Rice, MD, MSCI, associate professor of Medicine; and
- Wesley Self, MD, MPH, associate professor of Emergency Medicine.
Participants in the ACTIV Initiative include the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
