The largest independent clinical research site operation based out of Broward County Florida, Research Centers of America (RCA), has been selected to conduct COVID-19 vaccine trials implemented under Operation Warp Speed (OWS). RCA now is actively recruiting volunteers to participate in these studies while also working with the U.S. federal government and pharmaceutical sponsors, which developed the vaccine targeting the novel coronavirus. One of the trials RCA was selected for was Moderna’s Phase 3 effort: RCA is targeting between 300-500 participants for the Moderna trial alone.
The Phase 3 clinical trial is expected to include up to 30,000 participants in the United states, testing 100 µg of the investigational mRNA-1273. The sponsor’s primary endpoint: the prevention of symptomatic COVID-19 disease. Select key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by the novel coronavirus regardless of symptomology.
What is Research Centers of America Background?
Led by Dr. Howard Schwartz, Chief Medical Officer, RCA is an independently owned research company. RCA specializes in conducting Phase 1-IV vaccines and CNS trials for pharmaceutical and biotech companies. RCA commits to delivering solid science and applying strict adherence to GCP/ICH, as well as training according to FDA Code of Federal Regulations. The firm employs between 25 and 50 employees.
RCA reports its somewhat unique for starters, because its early phase unit (where Phase 1 safety studies are conducted), late phase space and sleep lab are adjacent to each other. This proximity benefits patients by simplifying the process. Additionally, the site has partnered with Fort Lauderdale Behavioral Health Center to conduct inpatient and outpatient psychiatric trials. Additionally, the site embraced Verified Clinical Trials, a leading clinical trial data.
Recently, RCA announced expansion with a build-out planned for a second Phase 1 unit, 800 compliant pharmacy, PK lab as well as Investigator offices and multiple exam rooms. This state-of-the-art early phase unit will contribute an additional 44 beds and house its own waiting room, check-in station, procedure room, nurses’ station, kitchen, equipment charging room, and entertainment and dining areas.
Principal Investigator Background
Dr. Howard Schultz, Chief Medical Officer for RCA also serves as Principal Investigator on vaccine and Phase 1 trials and as a Sub-Investigator on most other trials. Dr. Schultz has been involved with over 1,000 clinical trials in multiple therapeutic areas. Board Certified in Internal Medicine and Gastroenterology, he has practiced medicine in Florida for over 30 years. His mission now: make RCA the premier clinical trials site in South Florida.
Recent visitors helped contributed to his goal as Dr. Howard Schwartz met with several news media channels and was also part of a roundtable discussion with Vice President Mike Pence, school leaders and members of the Miller School of Medicine, along with several other researchers working to end the ongoing battle against the Coronavirus.
RCA, according to their website, have worked with prominent industry sponsors such as Gilead, Merck, Mylan, Novartis, Roche, Pfizer, Otsuka, Novo Nordisk and others. An impressive list.
Call to Action: If you are based in South Florida (Broward County) and interested in volunteering for the Moderna vaccine clinical trial, please follow the link here.