Whether you have ADHD, can’t sleep, wheeze with asthma, eat way too much in one sitting, are a smoking teenager, or have sunk into depression, the Florida Clinical Research Center may need you to step up and volunteer for a drug study.
All of these conditions have been the past or ongoing focus of the privately owned research center, located in a sunny suite of offices on Cooper Creek Boulevard.
The center tests medications for pharmaceutical companies, with some of its clinical trials including children as young as six. Many times, it is studying how existing drugs can be used in different ways; for instance, whether a medication works to treat a condition beyond what was initially approved for, or how a larger drug dosage compares to a smaller dosage.
For this, the center needs a steady stream of volunteers who are willing to participate -- and in certain studies won’t know if they are taking the medication being studied or a placebo.
The staff spends significant time on community outreach, from sponsoring an artist at last weekend’s Sarasota Chalk Festival to using social media.
One study, on binge eating, now finishing up, attracted dozens of calls from women and men. Recruitment was through flyers, newspaper notices, contact with groups such as Overeaters Anonymous, and health fairs.
The central qualification to enter the study was binging at least three times a week. “Binges” are described as eating, say, a whole bag of chips, or six tacos, or half a large pizza at one sitting. No purging, just binging.
“Binge eating disorder is just now being recognized. It creates a lot of guilt and self-esteem issues,” said Andrew Cutler, chief medical officer and founder of the center.
The center needed only about 10 patients. It is one of 30 sites in the country gathering data to determine whether a medication is effective against binge eating.
As for all studies, Cutler isn’t allowed to say what drug is being tested or whether it is working. Drug companies consider the studies to be proprietary information; the results will be known if and when the results are published.
Volunteers also sign confidentiality agreements when they enter studies.
They aren’t supposed to tell the name of the drug or other details. However, they are allowed to share that information with their doctor, said Cutler.
Turning away participants happens when potential volunteers don’t meet the criteria for the studies. To gather reliable data, clinical trials specify the characteristics of who qualifies, such as health condition, age and health history.
In August, about 25 percent of the 215 people who called the center were eligible for current studies.
Unlike the binge-eating study, other studies don’t attract a flood of volunteers. The center is still looking for more teen smokers to test a drug that will help -- or not help -- in kicking the habit. Eligible participants must be at least 12 and not older than 19.
The drug already has been well tested and has a safety record, but this study will provide more information about how it works for adolescent smokers, said Cutler.
“We thought this would be a no-brainer. We know how many teenagers smoke,” he said.
The center’s community relations coordinator, Jamie Smith, speculates that the study’s requirement for parental consent may be a roadblock for some teens. She has talked before groups of teenagers, who seem interested until she mentions they need a parent’s OK.
Meanwhile, about 30 percent of the studies at the Florida Clinical Research Center are on medications that treat ADHD in children and adults.
In one study, a classroom setting was used to compare the effectiveness of two dosages of an ADHD drug for children aged six to 12.
“Raters” sat in the back of the classroom to watch for whether children were fidgeting, bothering their neighbors or exhibiting others signs of ADHD.
Mental health disorders, including depression and bipolar disorder, have also been a significant focus of the center. Cutler has plans to expand into women’s health issues and other medical conditions.
Cutler is trained in both internal medicine and psychiatry. He graduated from medical school at the University of Virginia, where he also was a researcher.
At that time, in the early 1990s, drug research was still mostly being done at universities. Increasingly, though, drug companies are now working with private centers to help test medications, said Cutler.
He began the Florida Clinical Research Center in 1998 with a location in Orlando and then expanded with a second location in Bradenton.
Cutler estimates that 40 to 50 percent of study volunteers at the research center don’t have health insurance. A perk is frequent and thorough medical care. The first visit may be three to five hours, with weekly follow-ups during the study.
The thoroughness has picked up undetected conditions such as hepatitis C and revealed that some patients diagnosed with depression actually have bipolar disorder.
Volunteers are paid a small amount of money, about $35 to $50 per visit, to compensate for their time and travel expenses.
The Florida Clinical Research Center is at 8043 Cooper Creek Blvd., Suite 107, Bradenton. For more information, call 941-747-7900 or visit www.flcrc.com.
Susan Hemmingway, Herald health correspondent, can be contacted at firstname.lastname@example.org.