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The clinical trials research team successfully completed its first clinical trial over the summer after eight years of managing more than 140 patients. A second clinical trial with 36 patients has been under way for three years.
The team’s demonstrated proficiency in recruiting and caring for patients, as well as following trial procedures and documenting findings, has resulted in offers of other trials, including the two new ones.
“Our specialty is long-term cardiovascular outcome trials,” said Debbie Weeks, a nurse with 33 years of experience. She has worked more than 10 of those years with Carol Wysham, a Spokane endocrinologist and an adjunct research professor at the College of Pharmacy, who heads the team.
Two new diabetes studies
The new clinical trials are both diabetes-related. One is sponsored by Duke and Oxford universities and the other was developed by the Population Health Research Institute in Hamilton, Ontario, Canada, and offered to WSU through the University of Washington.
The Duke trial will compare whether the medication Januvia® makes a difference in cardiovascular outcomes in diabetic patients. Funded by Merck Inc., the trial will have study sites in 33 countries and follow 14,000 patients for at least three years.
The population institute’s trial will test whether adding a thiazolidinedione medication to the drug regimen of a person with diabetes will reduce the risk of heart disease, and whether the addition of vitamin D will decrease the risk of death and/or the risk of developing cancer. Funded by GlaxoSmithKline, the trial will have sites in 29 countries, and approximately 16,000 patients will be followed for up to 10 years.
Anyone interested in participating in a clinical trial can contact Shannon Yedinak at 509-358-7729 or Debbie Weeks at 509-358-7733.
Diabetes trial completed
Weeks, Wysham and two other college employees with medical backgrounds made up the team that handled 142 patients for the just-completed National Institutes of Health (NIH) diabetes trial. The team will participate in follow-up of these study patients for another five years.
WSU Spokane was one of more than 70 clinical trial sites for the NIH study, which was designed to shed light on whether maintaining specific levels of blood sugar, blood pressure and cholesterol would reduce cardiovascular events – such as heart attacks or strokes – in persons with type-2 diabetes.
The WSU team also participated in two sub-studies of the NIH trial one that focused on the patients’ memory and the other on eye disease in relation to blood sugar, blood pressure and cholesterol goals. Study results have not been released.
The trial participants were required to follow certain regimens and report at regular intervals to the Health Sciences Building on the WSU Spokane Riverpoint campus, where the team and their examination rooms are located.
Patients are drawn to participate in clinical trials because of the free medical care, medications and extra attention that being part of a trial affords, Weeks said. The College of Pharmacy site rates high in its ability to keep patients coming back, she said.
Cholesterol study in progress
Because of the first trial known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial the NIH also enlisted the team’s participation in another national study that started in 2006 and will last five years.
It compares how two different FDA-approved treatments for lowering cholesterol levels may reduce the risk of heart attacks, stroke and other cardiovascular complications. There are approximately 100 study sites for the trial, co-sponsored by Abbott Laboratories, which will look at the medication Zocor® alone and also in conjunction with Niaspan®.
New team member
In addition to the new trials, the clinical trials team has added new member Joshua J. Neumiller, an assistant professor of pharmacy at WSU and an experienced researcher and licensed pharmacist for the past four years. He is a certified diabetes educator, certified geriatric pharmacist and has been with the College of Pharmacy since graduating from the WSU pharmacy program four years ago.
Weeks got her national certification in clinical research more than 10 years ago, and she renews it every two years through continuing education. She and the college’s finance officer completed an intensive training for managing clinical trial finances, and they work closely together on trial budgets to ensure they do not cost the university money.
“Careful review of the trial protocol is necessary,” Weeks said. “When a trial is offered to you, you want to make sure you aren’t going to go broke before you say yes.”
More information is available on the team’s web page at:
https://www.pharmacy.wsu.edu/pharmacotherapy/clinicalresearch.html
