North Alabama Research Center (NARC) and a sister site called Medical-Affiliated Research Center of Huntsville gear up to conduct major COVID-19 vaccine clinical trials sponsored by the BioNTech and Pfizer partnership. The site operation and study is overseen by Tonya Pryor at the Athens and Huntsville-based research centers. These sites have partnered with Pfizer in the past, successfully, and hence were selected for this pivotal Phase 3 clinical trial investigating the safety and efficacy of mRNA-based BNT162.
U.S. Fed Gov. Makes Large BNT162 Purchase
This week, the companies announced that the U.S. government made an advanced purchase of 100 million doses for $1.95 billion if the vaccine, BNT162, in fact provides to be safe and efficacious and therefore ultimately approved by the U.S. Food and Drug Administration (FDA). Moreover, the U.S. federal government secured an option for up to 500 million more doses.
The Study in North Alabama
The next major clinical trial will involve 150 clinical research sites around the United States. The Phase 3 trial will come to North Alabama thanks to the sponsors selecting the two sites Ms. Tonya Pryor manages. As sites acknowledge across the country and beyond, those in North Alabama as elsewhere are considered “medical heroes” for participating in this critical, historically relevant effort.
The sponsors have agreed with the Athens and Huntsville, Alabama sites to recruit up to 300 participants for the study: 50% will receive the vaccine and another 50% the placebo in this randomized, placebo-controlled study. The hopes are that enrollment commence by August, reports Pryor to the local press called the Moultrie Observer.
How did these two Sites get Selected?
It all comes down to relationships and performance. TrialSite can inform that the former can only develop with the latter in the world of high stakes Phase 3 clinical trials. Research sites must demonstrate over time that they can not only conduct high quality, compliant research but that they can recruit participants in promised numbers. If a site doesn’t run an excellent, patient-centric operation, than the task of recruitment becomes ever more difficult regardless of the study.
In the case of these sites Ms. Pryor reports that the clinics have worked with several drug companies including Pfizer for a long time. A known and trusted relationship is importance, and that isn’t an exception here as these North Alabama sites have worked with Pfizer on other vaccine studies in the past. Mr. Pryor reports, “That makes it easier for us and the pharmaceutical company.”
The Site Operator
Ms. Tonya Pryor runs these sites and brings a wealth of experience to the clinical trials site process.
Target Participants in North Alabama
The research sites ideally would like to recruit those high-risk individuals such as “frontline people” that for example work in health care, first responders or other professions where they are in contact with people often and their probability of infection rises. That could also include those that may be older or those with underlying medical conditions and hence face greater risk if they are infected, reports Pryor. Mr. Pryor emphasized, “The majority of people who get COVID-19 are not going to get severely sick and be on a ventilator in ICU, but those people who are, they’re the ones who need to be in this study.”
Rigorous Monitoring & Highest Level of Care
The study teams here will carefully and systematically monitor the study participants, on the lookout for the development of antibodies and monitoring their overall health. The participants will also have a patient diary that they can use to capture any symptoms for example. As part of clinical research, volunteers receive free medical care including COVID-19 testing, antibody testing, EKGs, blood and lab work, physician assessments and ore reports the local press.
Some participants that don’t meet the inclusion criteria cannot participate. But those that do meet the criteria could be compensated for time and travel.
The Clinical Trial Sites
Medical Affiliated Research Center (MARC) is a multispecialty research center that conducts Phase 1-4 clinical trials. With 7,500 square feet devoted to research trials, the site staff includes a urologist, gynecologist, dermatologist, neurologist and more. They report to have 12 research coordinators and a sizeable research data base with 500 healthy volunteers acquire via advertisements, etc. The site was founded by Dr. James G. McMurray, a well-known Huntsville, AL-based urologist back in 1974.
The North Alabama Research Center (NARC) was established in 2007 as a premier multi-specialty medical research center. Based in Athens, AL, NARC participates in a wide range of clinical trials to evaluate new pharmaceutical therapies and medical devices developed to improve the treatment of specific diseases. Ms. Pryor is associated with the management of this site as well.
Call to Action: If you are based in North Alabama, consider participating in the BNT162 Phase 3 clinical trial. Visit their website here.