Trial site organizations: if you are too busy, big sponsors may pass up on you. Or could this also imply they think you’re too small? That’s what happened to the Palm Beach Research Center in Palm Beach County, Florida recently reports David Scott. Sponsors will consider a number of factors when analyzing trial sites including estimation of capacity, resource, wherewithal to recruit patients and deal with high volume, etc. The trial site certainly has an impressive track record of meeting enrollment targets based on data they share with the public.
Recently, CBS12 interviewed Scott who told the local news channel that they local trial site applied to participate in the KidCOVE study, which will enroll over 6,700 children from infant age (six months old) all the way to 12 years old. TrialSite recently reported on this study and by the number of emails received expressing concern it’s certainly controversial at least for some. Others are doing the hard math, such as Adria Cimino with Motley Fool, calculating that this age cohort could represent at least $1.5 billion in additional revenue.
Moderna set up a website for the study, which communicates more details about the study. The company emphasizes the importance of diversity in research, vital to ensure the mRNA-based vaccine can protect people of all ages, from all backgrounds, and the like.
The Phase 2/3 study will investigate the safety and effectiveness of mRNA-1273, the experimental vaccine currently authorized under emergency use by the U.S. Food and Drug Administration (FDA). TrialSite recently showcased the study based on the clinicaltrials.gov disclosure here.
What about Risks to Infants?
TrialSite did receive some communications from some parents expressing concerns about volunteering an infant between 6 months and a year for such a study. Many parents are confident. CBS12 News reporter Stefany Valderrama recently asked Scott, “As a father would you feel confident putting your children through a study like this?” He replied, “Absolutely,” noting the only downside is, of course, that the child may receive the placebo. But this really isn’t a risk. Placebos in clinical trials aren’t concocted to introduce risk.
The Moderna vaccine is considered incredibly safe and effective and effective.
What about the Trial Site?
Based in Palm Beach, Florida, Palm Beach Research Center has been in operation since 1994. An independent trial site organization, they specialize in working with pharmaceutical sponsors or contract research organizations (CROs). The site was selected for the prominent Storm Chaser trial, which focuses on the AstraZeneca dual long-acting antibodies in two major trials—one to test the Vanderbilt invented therapy as a prophylaxis and the other for post-contact with COVID-19.
The organization appears to have an impressive array of capability as well as equipment to support large industry trials. Of course, they are also situated in a highly populated, diversified area. The Palm Beach area is part of the broader “Greater Miami” with about 6.2 million residents.
This population is incredibly diversified making it an attractive area for research sponsors. Hispanics make up about 44.2% while Blacks account for 21.2%. White equals 31.1%.
On the topic of patient recruitment, the track record, if correct, speaks for itself.
David Scott has led the organization since 1996. With about 40 employees, TrialSite estimates the firm is close to $10 million in revenues if not more given the extent of demand since the onset of COVID-19.