Department of Medicine sees an Increase in Funding from Clinical Trials for Second Straight Year
The purpose of a clinical trial is to determine whether a new treatment option is safe, effective and a better alternative to current standard care methods. Clinical trials provide physicians an opportunity to test new therapeutic ideas to determine their effectiveness. (The above linked site provides a more in depth description of a clinical trial).
Clinical trials in the Department of Medicine have increased by 48% from fiscal year 2009 to fiscal year 2010 and over the last three fiscal years there has been a significant rise in funding. These clinical trials are conducted not only at Froedtert Memorial Lutheran Hospital but also at the Zablocki VA Medical Center. When asked about the benefit of clinical trials, Dr. Barbara Bresnahan, Associate Professor in the Division of Nephrology stated, “It gives us the opportunity to offer newer, novel therapies to our patients. In the end we hope this translates to better patient outcomes using both existing and newer therapies.”
The Department of Medicine is also an active participant in the TRU (Translational Research Unit). Many times during Clinical Research you might hear the term phases, which describes the study’s progression with a particular drug. Below you will see what these terms actually mean:
Phase I trials
Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
Phase II trials
The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III trials
The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information which allows the experimental drug or treatment to be used safely.
Phase IV trials
Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.
Dr. David Marks, Professor in the Division of Cardiology describes the Cardiovascular Clinical Trials Program as “invaluable for faculty development, retention, and fellow training. We also use the program to offer unique pharmaceuticals and devices in trial based environments as well as for registries and compassion use. The growth of Compassionate Use Devices has escalated with current patient need and this service is not supported by our hospital partners. In summary, the Clinical Trials Program promotes unique and vital academic clinical opportunities to both faculty and patients.”
Many clinical trials go through years of study before going to market and have helped several patients within the Department of Medicine live a much fuller life and improve their outcome. There is a bright future ahead for the department’s involvement in clinical trials, with each division stepping up and continuing to build on our reputation of national and international research and scholarship.
Article written by Antonio Grasso, Nephrology