New London practice makes drug trials its business
New London - Hot flashes, Alzheimer's disease and multiple sclerosis are only some of the conditions being studied a stone's throw from Lawrence + Memorial Hospital at CCRStudies on Montauk Avenue.
Led for the past 14 years by principal investigator and medical director Dr. Robert M. Spitz, CCRStudies is one of the many small clinical practices across the country used by pharmaceutical companies large and small to study the effects of medicines on willing participants.
"We are not here to treat someone's condition; we are here to test a medicine," said Diane Palmer, a registered nurse who serves as site administrator for the clinical-trials practice. "If you experience a benefit, that's a wonderful advantage to you - but we can't say you'll experience a benefit."
In fact, as in most clinical studies, a percentage of the participants who come to CCRStudies for an experimental treatment often receives a placebo - unless the study is comparing the effectiveness of two different medicines already on the market.
At Coastal Connecticut Research LLC, the umbrella business that operates CCRStudies, clinical trials are conducted on mid- to late-trial experimental medications as well as on after-market treatments already found to be safe and effective. Most of CCRStudies' trials involve only five to 25 patients, but similar testing is often being conducted at dozens of other sites on thousands of other people across the world to make sure a broad cross-section of patients is being represented.
"I love the people here, they're so nice," said Stephanie Messier of Plainfield, who stopped in to the clinic earlier this month in the midst of her fourth clinical trial. "They're almost like family."
Messier said she first heard about the clinical-trial site while attending a bridal show with her daughter and decided to participate.
"If somebody doesn't do it we wouldn't have the drugs," she said. "It's nice. It's doing something to give back."
Patients get a free physical exam before and after the studies, which can save those without insurance - or with high deductibles - a large amount of money. In addition, volunteers receive a stipend each time they drop by the office for an appointment - an amount that varies depending on the length and type of study, but often amounts to about $50 to $125.
Most patients, said CCRStudies staff, are not involved in clinical trials for the money, though it does help. Instead, patients are hoping to advance medical science, they said.
"These are the type of people who are blood donors," said Palmer. "It's a whole different breed of people."
The staff at CCRStudies makes sure to review with participants what to expect from taking a specific medication - side effects that can include dry mouth, constipation and other usually manageable problems. Occasionally, a participant might have to withdraw from a trial because of an adverse reaction, Spitz said, but that is a rare case.
Participants are sometimes required to keep journals of how they felt while involved in a study. It is difficult, though, to monitor whether they are actually taking the medication because they visit the clinic every few weeks rather than daily.
"At some point, you just have to trust," said Spitz, who spends one day a week at CCR Studies while maintaining a gynecological practice downstairs.
Spitz said he gets a lot of satisfaction from his clinical work, often seeing positive effects in the participants - though neither he nor the patients are ever aware of whether the medications dispensed are placebos or the real thing. Most participants come from a 15- to 20-mile radius, but a few have come from as far away as Bridgeport and Hartford.
Clinical trials used to be conducted largely at big-city medical centers, but pharmaceutical companies in recent years have evolved a new system that includes smaller community settings, Spitz said.
"To get meaningful clinical results you really need to test in a diverse population that reflects the community where medications are going to be used," he said.
Much of CCRStudies' trials have involved women's medications. Among the trial successes that have turned into marketed medicines were Brisdelle, a treatment for hot flashes; Vesicare, for overactive bladder problems; Reclast, for osteoporosis, and Vagifem, a menopausal treatment.
The New London office has conducted trials for a wide variety of pharmaceutical companies, including some of the largest: AstraZeneca, Eli Lilly & Co. and Pfizer Inc. Still, it's difficult to get the word out about clinical trials, and CCRStudies often relies on patients in its database while also reaching out to find new participants by placing booths at community events and handing out literature.
MaryLou Gannotti, public relations and communications specialist, said one of the ways the clinic reaches out to the community is by offering free memory screenings to anyone who shows up to the office.
"We're a well-kept secret," Spitz said.
The data collected by CCRStudies is analyzed by representatives of the drug companies - now largely contract research organizations - as well as by U.S. Food and Drug Administration and pharmaceutical company auditors to make sure results are being tabulated correctly.
CCRStudies has conducted about 80 trials over the years. Spitz said the office must be doing something right because sponsors keep coming back year after year.
"We're big enough to be attractive to sponsors, but we're small enough for personal interactions," Spitz said.
l.howard@theday.com
Twitter: @KingstonLeeHow
BUSINESS SNAPSHOT
What: CCRStudies
Where: 342 Montauk Ave., New London
Principal: Dr. Robert M. Spitz
Years in Business: 14
Employees: 5
Phone: (860) 443-4567
Website: www.ccrstudies.com
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