Success comes in vials

Like many businesses, Central Kentucky Research Associates was struggling through 2008. Then it got a shot in the arm — literally.

Because of the company's expertise in vaccine research, it took in more money in 2008 than it had in five years, said Debbie Dyer, co-founder and chief executive of the company, which conducts drug trials for pharmaceutical companies.

In late 2008, the company landed a study of a bird flu vaccine. The study turned what had been a weak year into a strong one.

"It's feast or famine," Dyer said.

Central Kentucky Research Associates conducts medical studies for pharmaceutical companies. At any one time, the company operates 40 studies out of offices in Lexington and Mount Sterling.

The company finds patients to participate, provides the medical care needed for the study and reports the results (as raw data) to the drug companies.

The drug companies pay CKRA a negotiated, per-patient rate for their services. How much CKRA makes varies by study.

Dyer started the company in 1991 with Jacquie Smith, who died in 2005. At the time, the two were nurses working in research at the University of Kentucky.

At first, they did everything on their own and worked as nurses on the side.

Since then, the company has grown into a business with 22 employees. In 2008, the company had $3.4 million in gross revenues, said Ginger Arthur, director of operations and finance.

These days, the company doesn't have to fight to get business.

"We turn down more studies than we do," Dyer said.

The company's offices on Richmond Road, just outside Man o' War Boulevard, look like plush doctors' offices. There's a large TV, snacks and coffee for the patients.

The clinical area looks like a typical doctor's office, with small rooms for patient consultations and a lab for the collection of blood, urine and other samples.

The company got into vaccine research three years ago when a pharmaceutical company was testing a new form of flu vaccine for children — FluMist, a nasal spray now on the market.

Since Sept. 11, the U.S. government's interest and spending on vaccine research has increased. Right now, the company is working with the Office of Homeland Security on protocols for studies of vaccines against smallpox, botulism and plague. So far, Dyer isn't being paid for that work, but she considers the time an investment.

"I want those studies," Dyer said. "I want a part of that."

The largest cost for the business is recruiting patients.

Drug companies value how fast a company can recruit patients, complete the study and send back accurate data, Dyer said. Central Kentucky Research recruits through newspaper, radio and television ads. It sends out a newsletter to more than 28,000 potential subjects. It also maintains a database so it can search for patients with certain conditions. The company uses fliers on cars, Facebook and e-mail blasts to contact potential subjects.

For every 15 patients the company interviews for a study, five return for a more in-depth consultation. Usually only two of those five ultimately qualify for the study, Dyer said.

Some patients participate because they want access to new treatments, others because they want to advance medical care, and others do it for the money, said Susan Lanthorn, director of business development.

Patients are reimbursed for their time. The amount of reimbursement depends on the length of the study, how often the patients have to come in and how invasive the procedures are. Studies requiring colonoscopies pay more than studies that just require blood withdrawals. Patients are paid about $30 for an average doctor's visit.

A restless leg syndrome study that the company is now enrolling requires an overnight sleep study and almost three months of pill taking and monitoring by doctors. That study reimburses participants $1,900, said Samantha Hutcherson, who recruits patients.

Last Thursday, Patsy Gibson came in for a study of a vaccine against whooping cough.

Gibson, 79, has done four or five studies in the past 10 years. Gibson says she doesn't participate for the money. Rather, she wants to contribute to medical research.

"It's what I can do for my children and grandchildren and great-grandchildren," she said.