What is Clinical Research at Pen Bay Medical Center?
by Caroline Knight, CCRP, clinical research specialist
What is Clinical Research?
Clinical research, also referred to as clinical trials or research studies, involves researchers who directly observe a person or people, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method or behavioral change. The research sometimes involves:
giving patients drugs that have not yet been approved by the FDA.
giving drugs that are already approved, however, there is still more to be learned about the drug (such as when it is given to patients with heart disease).
use of an investigational device (such as a new blood sugar monitor).
determining the best treatment plan for a particular group of patients.
Is Clinical Research Safe?
Clinical research is highly regulated. With drugs that have not yet been approved (investigational medications), research is closely monitored by the FDA. However, there is still more that needs to be learned about the medications.
Additionally, there is an independent board at Pen Bay Healthcare whose only responsibility is protecting the rights and safety of patients involved in research studies. They even have to approve ads put in the newspaper!
Did You Know Pen Bay Medical Center Has An Active Clinical Research Department?
The department's medical director is Robert Stein, MD, neurologist. There are two staff nurses, Caroline Knight, RN, CCRP, clinical research specialist, and Tara Murray, RN, study coordinator. Other physicians conducting research studies are: Neal Yetman, DO, Mark Vannorsdall, MD, Nadia Ramdin, MD and Ralph Hamill, MD.
What Kind of Research is Being Done at Pen Bay?
The Clinical Research department at the hospital is currently enrolling patients in eleven clinical research studies. Some of the areas of study are:
Gout and Heart Study
This study is comparing two approved treatments for gout. The purpose is to determine if either drug is better or worse for patients with high risk of heart attack. Patients receive study medication for about three to five years.
This research study aims to determine the effectiveness and safety of giving a medication as bridging anticoagulation to people with atrial fibrillation who require temporary interruption of warfarin (Coumadin) because of surgery or another procedure.
Diabetes and Kidney Disease
Three different studies are being done with patients who have both diabetes and chronic kidney disease. Two of the studies are with new anti diabetic medications while the other is with a medication that may help with the kidney function.
Anemia and Kidney Disease
This study is with a medication to help boost the body’s production of blood cells in patients who have anemia caused by their chronic kidney disease.
Three different studies for patients with breast cancer are currently enrolling. Each involves chemotherapy and one of them also involves radiation therapy.
This study involves the use of a medication to prevent colon cancer recurrence in patients who have had colon cancer removed.
Please call 596-8959 for more information or email firstname.lastname@example.org. Patients do not need a referral but should always feel free to ask their physician whether participation in a clinical study is appropriate for them.
Caroline Knight RN, CCRP, is a clinical research specialist at Pen Bay Medical Center.
L-R: Caroline Knight, CCRP, clinical research specialist, and Tara Murray, study coordinator.