Testing on Tulsa Time

On average, it takes a new drug more than 12 years, and nearly a $1 billion, to travel the road from inception to pharmacy shelf, and today an increasing number of new drugs find their paths, and profits, running through Tulsa.
According to Dr. Steven Landgarten, chief medical officer for Hillcrest HealthCare System and principle investigator for the Utica Park Clinic Research Department, ongoing clinical research at Hillcrest Hospital has helped bring a number of experimental drugs to fruition.
“There are currently at least six drugs on the market in which we participated in the clinical trials and helped develop,” he said. “We do 15 to 20 new studies a year, so over the years that we have been doing clinical research, we have participated in about 150 clinical trials.”
The research, said Landgarten, is centered on patient need, not the desire for increased physician income.
“Clinical research is not all that profitable. It certainly covers its costs in the sense that it pays the salary of the staff that is working. It pays for the professional time of the physicians involved. There is a relatively small margin, but as in every other business, you are doing well by ‘doing good,’” he said.
“The clinical research at Hillcrest is done not so much for the profit, but for the benefit of not only this generation of patients but for the next generation of patients. Everyone will benefit from the next generation of drugs we help develop.”
The drugs tested in Tulsa are not here by mistake, Landgarten said. They are chosen as being mutually beneficial to the patients and drug companies.
“We have a population that has a high prevalence of diabetes, high blood pressure, high cholesterol, arthritis and certain infectious diseases. So what we have tried to do is select clinical trial participation in areas where our patients could benefit from participation,” he said.
Growth
Landgarten said Hillcrest has been performing clinical research since 1999, and during that time, the research department has grown considerably.
“About seven years ago I was asked by the Mayo Clinic to participate in a clinical research trial,” Landgarten said. “They were asking doctors from around the country to help in their trials. It was the first time I had participated in clinical research in a number of years.”
“We became interested through that, and the trial worked very well. It was a positive experience.
“So the Hillcrest Medical Group established a research department and began taking on our own,” he said. “Since then, the Hillcrest Medical Group has established a full-time department. What we do is attempt to find research studies in areas of clinical interest that our patients might participate in.”
Since that time, Hillcrest has affiliated with Research Solutions, a
Little Rock, Ark.-based site management organization and specializes in the enhancement of site performance through patient recruitment.
“Research Solutions provides us with a set of services. Research is very federally regulated. As part of that regulation you have contractual relationships with the sponsors. You have patient recruitment and selection, and compliance with a very complicated set of regulations that govern each clinical trial,” Landgarten said. “You have regulations that are principally for the protection of the research participant. This requires full time staff.
“The association with Research Solutions allows me to play doctor and researcher and allows Research Solutions to bring in the technically qualified staff to do the compliance and patient safety and regulator activities that are part of research.”
Balance
Kandace Jetton, site manager for Research Solutions, said patient education is another responsibility of the company.
“Research Solutions stresses patient education. We tell them before the study begins what is going to be done and what to expect. We also have to emphasize to them their obligations to the study and our obligations to them,” she said.
“It is a time consuming thing for a patient to enter a study, but as bad as we need patients, we have to have committed patients, and we have to be obligated to them.”
The Hillcrest clinical research department has grown since the first studies were performed in 1999 and could continue to expand. But according to Landgarten, expansion should not be entered into without proper “balance.”
“Our research department in 1999 was me and my nurse, and we did one study. Today we have a staff of 5 and we do about 20 studies a year for the Hillcrest Medical Group.”
“There is a balance that is reached in growing clinical research, and it is balanced by several factors: one, the time of the physicians; two, the number of trials that will benefit our patients, and three, the number of patients willing to participate in the trials. We feel we reach our balance at about 20 trials per year.” ?



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