The Project Lightspeed initiative has come to Nashville, Tennessee. Clinical Research Associates, a trial site organization was selected by Pfizer to participate in the Phase 3 pivotal clinical trial investigating the efficacy of BNT162, the vaccine program originating out of Germany via BioNTech. Clinical Research Associate was asked to bring in a considerable amount of volunteers and wisely decided to reach out with the local county health department: Metro Public Health Department, Nashville/Davidson.
Based in Nashville, TN, Clinical Research Associates was founded in 1990 and has accomplished over 650 clinical trials. Led by Endocrinology, Diabetes and Metabolism specialist Dr. Stephen Sharp, MD, the trial site organization sought out the assistance of the county public health operation. A smart move, as this public health agency, Metro Public Health Department, Nashville/Davidson, would have access to many tens of thousands of potential volunteers and this would be the agency involved with actually administering the vaccine should it be approved.
COVID-19 in Nashville Area
COVID-19 has hit Tennessee generally fairly hard as the state has 6.8 million people ranking it 16th in the U.S., and ranks 11th for COVID-19 cases with 139,175 cases along with 1,488 reported deaths. Nashville is part of Davidson County, which has a population of 671,000 and a metropolitan area totaling nearly 2 million individuals. Only Shelby County (Memphis) has more COVID-19 cases and deaths in the state. Thus far, 24,840 cases have been reported in Davidson County or about 18% of the state’s total cases. With 242 reported deaths, public officials report that the “city is showing slow progress against COVID-19, but the seven rolling day average of new cases per 100,000 needs to come down before things get back to normal.” Davidson County currently remains in “modified Phase Two” reopening stage meaning that restrictions are loosened but by no means are things back to normal.
Racial disparities in the form of health inequity manifest early on in the pandemic has Blacks experienced disproportionately high death rates in a similar trend to across the country.
Public Health Joins a Clinical Trial
Nashville is the county seat for Davidson County and is under a metropolitan, consolidated local government. Metro Public Health, as it’s called, will have access to a diverse array of individuals, far more than a small private research organization. Director Dr. Michael Caldwell shared for the press release that Pfizer as well as other vaccine sponsors reached out to Clinical Research Associates about conducting clinical trials in Nashville. In a smart move, Clinical Research Associates reached out to the county health department to tap into a far larger pool of potential study participants.
Not only did the public health department agree to open up access to patients but also would help with patient evaluations and oversight.
In a win-win, Caldwell emphasized, “So we’ll get first-hand, detailed knowledge of the science behind each of these vaccines. We’ll allow our community to learn about it, to participate if they want, if it’s right for them, and one day, hopefully, when we find out if one of these vaccines meets the threshold of being safe and effective, they get FDA approved, hopefully more of them.”
And apparently the county health department is going to be referring patients to other vaccine studies as well that are either operating in the area or intend on doing so.