About Clinical Trials
Physicians and researchers at the University of Louisville are working together to study the diseases they treat and to develop new compounds in the laboratory that can be brought to the clinical arena.
As a patient in the University of Louisville Healthcare system, you will have access to the latest drug development trials as well as state-of-the-art devices that will help scientists gain a better understanding of many medical conditions.
Funding for these trials is obtained from a variety of sources: government agencies, foundation grants, pharmaceutical companies, and other medical industries.
- What is a Clinical Trial?
Clinical Trials are a way for researchers to answer questions about the use of drugs, devices, and other interventions for the treatment of disease.
- Who can participate?
Not everyone will be able to participate in clinical trials. Each trial has a list of conditions that participants must meet to be accepted for enrollment.
- Why should I participate?
There are many reasons to take part in research. Some people participate to receive a potential new treatment that is not yet available. Others participate because they want to play a role in the advancement of medical knowledge. Participants need to be aware of the benefits and risks of the research and that their participation is completely voluntary.
- Are clinical trials safe?
Your safety and health is very important to your doctor, who will work with you to determine which course of treatment is best for you, including whether the risks, such as the potential for side effects, outweigh the benefits of participation in a clinical trial.
All research at the University of Louisville that involves human subjects must be approved by an ethics review committee before patients are allowed to participate. Ethics review committees are commonly referred to as Institutional Review Boards or IRBs.
In addition, clinical trials that involve investigational drugs and/or devices must be approved by the Food and Drug Administration (FDA).
Increasing Awareness - a National Challenge
Currently, there is an urgent need to increase patient participation in clinical trials. Recruitment into clinical trials is vital to the advancement of treatments and therapies for many medical conditions, especially in children, young adults, and those with cancer.
The longer it takes to complete a trial, the longer it takes to get a drug or device to the general public. There are many reasons for this national concern, one being lack of awareness, another being possible denial of insurance coverage for those participating in trials.
One of our goals at the University of Louisville is to increase awareness of the availability of clinical trials to the community – including both patients and area physicians. We are also working diligently with our hospitals, medical facilities, and insurance providers to ensure all patients have fair access to clinical trials.