my interview w/ a research nurse

This is the second interview I conducted while working on my project about pharmaceutical research. This time I interviewed Kathy Benish who runs the Kentuckiana Research Center with Dr. Steven Stern. She is a nurse, holding her masters of nursing as well as being a registered nurse, and has worked both in bedside nursing and clinical research.

1) What is the most rewarding part of your job? The most challenging? One of the most rewarding parts of my job is that due to my involvement with Research, I can be a part of changing the way medicine is practiced in the future. When I was bedside nursing, I felt my major impact was with the patient and their families. While I feel that this is very important, what we do affects people on a global scale. Some other rewarding benefits is getting to see the progression of the patients in the trials & being on the cutting edge of your specialty.

Most challenging parts are being the mediator & contact person between the patient & the Dr., the Dr. & the Sponsor of the trial, the CRO (Contract Research Organization) and the Dr., the IRB (Internal Review Board), and following the protocol (how the study is to be conducted). Sometimes I feel I am being pulled in a hundred directions, all for the same cause. Everyone wants things their way and sometimes that is just not possible. Then you have to remember that you are dealing with patients who don't always follow the rules for whatever reason(because they forget, they don't want to or they get sick & can't). Patient recruitment can also be very challenging.


2) How are research studies chosen? Clinical Trials are sponsored/funded by a variety of organizations or individuals such as: Physicians, Medical Institutions, Foundations, Voluntary Groups and Pharmaceutical Companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD) & the Department of Veteran's Affairs (VA). In our office, we choose trials that look at the disease processes that are pertinent to our practice.


3) Who plays a bigger role in funding research, the government or the pharmaceutical companies? This is a toss up. In our world, it is the Pharmaceutical Companies.

4) What part does the research center or Dr's office play in treatment development? The Dr.'s office/clinic is where the trials are being conducted. We are pivotal in getting new drugs to market or approved drugs for a new indication to market, new treatments for patients, and offer treatment options to patients that otherwise would not be available.


5) How would you explain the difference in phase1, 2, or 3 trials to somebody who had never participated in a clinical trial? Phase I: is the initial introduction of an investigational new drug into humans. First time tried in human beings, closely monitored, and designed to determine the metabolism and actions of the drugs in humans. Phase II: evaluates the effectiveness of the drug for a particular indication (like SLE or RA) to determine the common short-term side effects & risk associated with the drug. Phase III: are intended to gather additional information about the effectiveness & safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling (dose, route, etc). Usually done on a larger number of patients than the Phase I & II trials & monitors side effects closely. Phase IV: these are post marketing studies (drug has been approved) and are done to gather additional information on risks, benefits and optimal use.


6)What do you see as the most important thing that can be done to help increase the development of new, safer drug therapies for chronic illness? Patient education about trial involvement is important. Without patients, we could not do the trials and new drugs would not come to fruition. Money for research. Cost is a huge factor in developing new drugs. Insurance companies are reluctant to cover patients if they are in a trial. This is a big factor in patient recruitment. Security is also crucial. Researchers spend millions of dollars developing a drug only to have it stolen or sold to other companies & countries. Punishment for this needs to be swift and firm. I am sure there are many other factors beyond my comprehension but these are a few that come to mind.


7)What new treatments are you involved with studying and what phase are the trials in? We are studying several new drugs for Rheumatoid Arthritis, Lupus and getting ready to start a Gout trial and possibly Osteoarthritis Trial. We do not do Phase I trials in the office. Our trials are Phase II & III. We have a Phase IV trial that we have been doing for approx. 5 yrs that is also being used as a Registry for several disease states that allows Dr.s to see how others in their fields are doing things.