Holston Medical Group announced Monday that its facilities in Bristol, Tennessee and Kingsport were selected for Project Lightspeed, the global clinical research program centering on the mRNA-based BNT162 COVID-19 vaccine developed by BioNTech SE and Pfizer Inc. The worldwide trial seeking 30,000 has arrived in this part of Appalachia, in Northeastern Tennessee. The local Tri-Cities physician-owned group will seek up to 500 local volunteers to participate in this critically important pivotal clinical trial.
COVID-19 in Northeastern TN
Situated in Northeast Tennessee on the Virginia border in this part of Appalachia, the local Herald Courier reports that there are over 3,400 active COVID-19 cases across ten counties here by earlier this week. It’s reported that across the border in Virginia, that state’s Department of Health doesn’t have reports on active cases, but the local media reports up to 544 cases in the past couple of weeks across ten counties and two cities of southwest Virginia.
A Once in a Lifetime Study
Dr. David Morin leads research for Holston Medical Group serving as director of research. On a phone interview with David McGee from the Herald Courier, “I’ve been doing research for over 30 years. I’ve done hundreds of studies, and some of those medications have been life-changing. But I can’t think of a study that has the potential to have more impact on people’s lives than this study.” He continued for the local journalist, “It’s also the psychological effect we would have if there is something that turns out to be effective, whichever company develops it, that can help people develop some resistance to getting this COVID-19 virus.”
The Research Site: Physician-Owned Clinical Practice
What a compelling story. What started as a vision for a locally owned, patient-centric, physician-owned medical practice transformed from a small local practice in the late 1970s to a major regional provider including 60 locations, 225 providers, over 1,000 employees caring for over 60,000 patients per month.
Holston Medical Group (HMG) was represented in a vision that started back in the 1970s by Dr. Jerry Miller. He envisioned a new way to serve the community combining the critical values of compassion, integrity, and respect. On a mission, he and a small group of colleagues were on course to launch a physician-owned, family practice that could build enduring community relationships, deliver high-quality medical care and engage patients for better long-term health. By 1977, the vision became a reality when a grant from the Robert Wood Johnson Foundation enabled Holston Medical Group (HMG) to open its doors to their first patients.
Today HMG is among the most progressive of independent physician groups in the United States declares the practice website. They share on their website that over the last four decades, their “Family of Care” grew from a handful of family practitioners to a comprehensive, diversified group of nearly 230 primary care physicians, specialists and mid-level providers offering 24-hour medical/surgical service. With an emphasis on well-coordinated preventive care, the provider’s goal is to keep patients healthy and out of the hospital.
Clinical Research at HMG: Since 1996
In addition to providing comprehensive, patient-centric care, HMG manages a comprehensive research operation, offering patients in this part of Appalachia access to cutting-edge, advanced medicines. HMG has been impacting lives through the conduct of clinical studies since 1996 and includes the following results:
· Conducted over 800 Phase II-IV pediatric and adult clinical trials, with its physician-investigators having extensive experience in many disease states and conditions
· Conducts between 80 to 100 clinical trials annually, with over 20 primary and sub-investigators
· Is nationally recognized for its outstanding achievements in the field of clinical research
The BNT162 Study
The Phase 2/3 study is an event-driven trial that will continue enrollment on a rolling basis, enroll up to 30,000 participants at more than 120 clinical investigational sites around the world, in non-pregnant adults 18-85 years old. The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate for placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include the prevention of severe COVID-19 in those groups.
Dr. Rick Whiles, Bristol
Dr. Emily Morawski, Kingsport
Call to Action: If you reside in this part of TN or VA, consider volunteering for what is considered one of the most advanced, leading COVID-19 vaccine candidates. The Bristol office is at 240 Medical Park Blvd., near Bristol Regional Medical Center, and the Kingsport site is at 105 W. Stone Drive. The study team also seeks People of Color as it is important the COVID-19 vaccine trial participants represent the diversity in the United States and this particular region. See the recent story from the Herald Courier on the recruitment effort.