Fargo's Lillestol Research offers clinical drug studies

Twice a year, Darlene Braseth has been driving from Ulen, Minn., to Fargo to help test a new osteoporosis drug.

Moorhead resident Merwin Carlson volunteers for blood pressure and diabetes studies.

Both are patients of Fargo-based clinical research business Lillestol Research LLC, 1711 Gold Drive.

Launched in 2004 by Fargo internal medicine physician Dr. Michael Lillestol, the company does primarily Phase III clinical drug trial research for major pharmaceutical companies like Pfizer, Wyeth, Libby and Roche.

“Usually that’s the last phase before they try to seek approval from the U.S. Food and Drug Administration,” said Lillestol. “This is kind of the crucial step before they can get a drug approved.”

Phase III trials involve giving experimental study drugs or treatments to large groups of people to determine their efficacy and safety.

Lillestol Research may be one of 100 or more different sites doing the same trial. The studies involve a wide range of medical issues including asthma, diabetes, chronic kidney disease, hypertension, cholesterol, osteoporosis and rheumatoid arthritis.

Lillestol also does some Phase IV trials to assess drug risks, benefits and optimal use.

Carlson, 52, a regular patient of Lillestol’s practice at Internal Medicine Associates Ltd., Fargo, initially heard about the studies on radio, he said.

It was Lillestol who diagnosed Carlson’s diabetes problem before he decided to get involved in a study of the drug Metformin, which resulted in 22 visits over two years.

“They monitor me pretty close,” Carlson said. “That’s why I come to these studies.”

Conducting the clinical trials is a fulfilling experience, said Lillestol.

“Sometimes they have been working on these things for 10-15 years before I get to deal with them,” he said.

A family connection

Lillestol started doing clinical drug research in 1991 after receiving a letter from Roche Pharmaceuticals regarding an osteoporosis study.

Osteoporosis ran heavily in his family. Lillestol did several research studies through 1999, when he began working for Odyssey Research in Bismarck, doing research trials and serving as a consultant.

In 2004, he decided to start his own research center.

“I just felt like I wanted to do it a little differently,” Lillestol said.

He launched the business with three employees – including his wife, Mary, a registered nurse. Together, they started working on eight clinical trials.

Today, Lillestol Research employs 20 people at its 2,700-square-foot facility in Fargo’s Goldmark office park. The company is considering expanding again this year, Mary Lillestol said.

“We have done probably 60 to 70 studies since starting in 2004,” said the Lillestols’ daughter, attorney Kim Peterson, the company’s chief operating officer.

Son John Lillestol is director of operations and assists with day-to-day management of the business.

Now averaging 35-40 ongoing clinical trials, Lillestol Research revenues grew 50 percent each year through 2008, with 30 percent growth projected this year, said Mary Lillestol, company president.

This year the company opened a second site at Oakes, N.D., with two employees.

“Every week we get an inquiry from other pharmaceutical companies,” said Mary. “We decline them if they aren’t a good fit.”

Lillestol Research clinical studies are checked regularly by participating pharmaceutical companies.

“There are monitors that come in and check our work every week,” said Mary.

A different niche

Lillestol Research is similar to, but not the same as Cetero Research (formerly PRACS Institute), 4801 Amber Valley Parkway, Fargo.

It’s a question that gets asked often.

Cetero does primarily Phase I drug research involving healthy volunteers who stay overnight for extended periods of time, earning up to several thousand dollars per study.

“Our patient’s don’t stay overnight,” said Peterson. They may have a one-hour visit every three months, a couple of annual visits like Braseth, or four visits in the same week.

They receive a small stipend, usually $40 to $50 per visit and free medical care including medications, lab tests and examinations, Mary Lillestol said.

Some trials also pay mileage, she said.

Lillestol patients must undergo a screening process to be chosen for the drug trial.

“If they make it through the screening process, we randomize them into the trial,” said Mary.

Patients range in age from pre-teens to their 80’s, said Peterson.

“Many of our patients will finish one trial and ask if they can be in another one,” said Mary.

That’s usually no problem, however, a 30-day waiting period is required between sessions, she said.

“You’re a really good group to work with here,” Braseth told the staff after receiving a gift on her last visit Aug. 24.

“Our ace in the hole is that they (the FDA) want good sites,” said Mary Lillestol.

“We have proven ourselves. The patients in this area are very compliant. That’s who we are in the Midwest,” she said.

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