Newspaper article The Florida Times Union

A Shot in the Arm for New Drugs; Clinical Trials Benefit Patients and Pharmaceutical Companies

Newspaper article The Florida Times Union

A Shot in the Arm for New Drugs; Clinical Trials Benefit Patients and Pharmaceutical Companies

Article excerpt

Byline: Beth Reese Cravey

Once a month, Donna Toy goes to a medical building on University Boulevard, gets an injection of a cholesterol-lowering medication in her abdomen then heads off to work.

The injection may or may not help her cholesterol level.

And it may or may not ever be available to anyone else as an alternative to daily pills.

But Toy is one of a select few who are giving it a chance by taking part in a clinical trial at the Jacksonville Center for Clinical Research.

"If I can help ... anybody out there, that's the best thing," she said.

Toy views herself not as a guinea pig but as a crucial part of the pharmaceutical testing process. And as a heart attack survivor, she values the free health care and medical procedures she gets along the way.

"It's like piece of mind, getting extra care ... You're important," she said. "People have the wrong perception of clinical trials."

Crestor, Lipitor and Zocor for high cholesterol. Celebrex for osteoarthritis. Enbrel and Sinfoni for rheumatoid arthritis.

You may have seen the names of those prescription drugs. You may use them. They are among the drugs now on the market that underwent clinical trials at the Jacksonville Center for Clinical Research, founded in 1997 by cardiologist Michael Koren.

The largest of its kind in Northeast Florida, the center tests the safety, effectiveness and side effects of new medicines, therapies or medical devices on volunteer participants. The center is based on University Boulevard in Jacksonville but has seven other sites, including one in Panama.

The science of testing drugs, finding out what they do and don't do and helping improve them "is a really hot scene," said Koren.

"It is very fulfilling, it is why I do what I do," he said. "I have had the good fortune to have an impact."

The combined sites have 84 trials under way, with 223 participants, according to Dawn Robison, vice president of site operations.

"We have them going in and we have them going out," she said.

Participants receive free medical tests, services, counseling and treatment, access to physicians, invitations to educational events and, in some programs, money. Also, they are paid mileage and a stipend for their time.

Each of them sign a detailed consent form prior to any procedures or evaluations. But they "never waive their legal rights and are informed about their recourse should a situation arise where they feel they have been harmed by a study drug or procedure," said Amy Autry-Bush, who is in charge of patient recruitment at the center. …

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