UT’s Impact in Medicine
Small steps toward big breakthroughs
When Gerry Van Wambeke learned he had Parkinson’s disease 12 years ago, his then-neurologist offered little hope. After a friend referred him to The University of Toledo Medical Center, Gerry discovered the medical staff’s attitude toward his disease was much different. Armed with new hope and an even greater determination to win the fight against Parkinson's, he decided to help himself and others by voluntarily participating in a clinical trial.
Gerry is one of the hundreds of volunteers who have access to investigational treatments during clinical trials at UT Medical Center. Through these trials, Gerry, and others like him, play essential roles in advancing health care.
Clinical trials at UT
Any effective product must be tested before it is released. In the medical world, this is accomplished through clinical trials to study how procedures, devices, protocols and new medications can impact patients and their conditions.
“Clinical trials are the only way we are able to discover if a new treatment is safe and effective, which allows us to make these breakthroughs available to the public,” says Roland Skeel, MD, professor of medicine at UT and chair of UT’s Biomedical Institutional Review Board (IRB), a federally mandated body required to review all federally funded human research.
There are three main phases of clinical trials:
- Phase I – An investigational drug or treatment is tested on less than 100 patients for the first time. The results of this phase will help determine a safe dosage range and identify side effects.
- Phase II – The investigational drug or treatment is administered to up to 300 people to determine its effectiveness and further evaluate its safety.
- Phase III – The investigational drug or treatment is given to thousands of people to confirm its effectiveness, monitor side effects, compare it to current treatments, and collect data to ensure its safety.
When patients volunteer to participate in a study, UT provides an informed consent. “Physicians discuss the patients’ participation and provide them with an in-depth, written description of the study and alternatives – from the schedule of tests and medication dosages to the length of the study,” says Debra Gmerek, PhD, director of the Jacobson Center for Clinical and Translational Research at UT.
Clinical trials at UT Medical Center enable eligible patients to gain access to investigational treatments that are not widely available. During clinical trials, participants like Gerry receive expert medical care at UT Medical Center’s leading health-care facilities while contributing to research that could enable effective treatments to be released to the public.
UT Medical Center is conducting more than 90 clinical trials, the majority of which are in phases II and III. Trials currently running include:
- Breast Cancer-Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy – This phase III trial studies the treatments given to women receiving chemotherapy for metastatic breast cancer based on blood levels of tumor cells. Measuring blood levels of tumor cells may help doctors learn how chemotherapy works to destroy cancer cells. This study may provide doctors with insight on ways to plan more effective treatments.
- The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY) – This study tests patients with coronary heart disease to determine whether the drug darapladib can safely reduce the chances of having a cardiovascular complication, such as a heart attack or stroke.
- Assessment of Low-Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery – This trial is being conducted to determine if low-level laser therapy decreases pain in post-operative orthopaedic patients following lumbar fusion surgery.
- Risk and Resilience Factors for Combat-Related Post-Traumatic Psychopathology and Post Combat Adjustment – This study looks at the combat experiences of Ohio National Guard members and how those experiences impact their lives over time.
Safety is a priority
Close monitoring of each patient involved in any trial is essential. UT trials are carefully reviewed by the IRB and regulated by the FDA.
Made up of clinicians, scientists, educators and community members, the IRB determines if the risks of the study are reasonable in relation to potential benefits of the knowledge expected from the results. The board also reviews and approves any changes in the study and performs annual reviews. When appropriate, the IRB monitors the data collected to help ensure the safety of participants.
“The board works as a system of checks and balances. It maintains quality in the research, while protecting participants from unnecessary risk,” says Dr. Skeel. “We follow established principles required for conducting high-quality, ethical research. If we find that the study follows these principles, it is often approved.”
While UT as an institution is actively involved in improving the future of medicine, breakthroughs would not be possible without the volunteers.
“Like my doctors said to me, ‘It’s better to be proactive, rather than reactive,’” says Gerry, who has become an advocate for all types of medical research.
If you are interested in volunteering for a clinical trial at UT, contact the Jacobson Center for Clinical and Translational Research at (419) 383-6919.
