Tuesday, January 16, 2018
Business

Clinical trials conducted in Hernando play vital role in research, approval of new drugs

BROOKSVILLE — An opportunity to play a role in advancing medical knowledge, usually available only in university neighborhoods or bioscience parks, is firmly established right here in Hernando County.

Meridien Research, founded in 2000 and now with five Central Florida sites, draws on community volunteers — hundreds yearly from Hernando — to take part in clinical trials of medications that nationwide pharmaceutical and biotechnology firms are testing for eventual submission to the federal Food and Drug Administration's approval board.

Current trials at the site west of Brooksville are for pharmaceuticals to treat diseases of high concern nationally: Alzheimer's, arthritis, diabetes, cardiovascular risk and nine others.

Meridien CEO Tony Busa Jr., 64, explained: "For the most part, we're looking at a new drug or a comparative drug to demonstrate better efficacy versus what's on the market. It's the job of research to determine the value of a drug and its safety."

The drugs being tested already have passed Phase 1 animal testing. Phase 2 study, which Meridien performs, seeks mainly to determine safety parameters and how well the drug performs its intended function.

Meridien's clinical trials — more than 1,200, in which more than 50,000 volunteer patients have taken part — are conducted via contracts with research organizations and pharmaceutical companies, including such well-known names as Bayer, Merck, Pfizer and AstraZeneca.

The contractors pay Meridien, so study subjects receive free medications as well as free physician oversight and consultation between Meridien and the volunteer's primary care physician.

Volunteers, who might receive compensation for time and travel, ordinarily receive oral or injected medications — the real thing or a placebo — and might be required to keep a home journal of their diet, exercise, other activities, symptoms and their relief.

Trials have ranged from one day to six years, with each clinic visit an hour or two, said Brooksville facility manager Katie Leonard, a registered nurse.

Most studies require blood samples on scheduled visits. If tests such as an MRI, colonoscopy or optometry are needed, service providers in the local community are called upon, also paid by the contractor. Thus, Busa said, Meridien plays a role in the area economy beyond its own staffing.

A full-time medical doctor heads the 10-person Brooksville staff, which includes several part-time physicians plus nurses, lab technicians and medically trained study coordinators.

"Brooksville is generally receptive to requests for volunteers," Leonard said. "We get a lot of calls for our memory trials … diabetes and migraines."

"Most (volunteers) are trying to help find new treatments for their diseases," marketing director Stephanie Jones explained. "Many … have personally experienced (Alzheimer's and dementia) and what this means for themselves and their family members and are willing to do whatever it takes to prevent their children from having to experience the same thing.

"Pain disorders are also very difficult to cope with, and many come to us looking for new solutions or hoping to advance these treatments for others."

Volunteer intake begins with a phone call to Meridien and answering a few questions to see if the person qualifies for a particular trial. Among the factors determining qualification are age, gender, general health and the specific affliction.

The clinical research conducted at Meridien "plays a very important role in approval of new drugs," Busa said. "Drug discovery can't happen without volunteers."

With the country's gentrification and many diseases common in an older population, Meridien chose its Central Florida location because of its higher average age populace. "Various populations" are important to other particular trials, Busa added.

Other Meridien sites are in Tampa, St. Petersburg, Lakeland and Bradenton. Brooksville's highway access contributed to its selection as a site in 2005. The Brooksville clinic attracts volunteers, Jones said, from Citrus County, the Villages, Florida's Panhandle and as far away as Georgia.

Contact Beth Gray at [email protected]

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