What is a Clinical Trial?
Clinical Trials are studies that help doctors investigate methods to improve detection, prevention, or treatment of various disease conditions. Clinical Trials often involve testing the effects of a new treatment that has not yet been approved by the FDA for the specific species or disease. The treatment can be a drug, device, biological agent, or a behavioral or diet change. Entering your animal in a clinical trial may allow access to a test or treatment that otherwise may not be available. The results of trials can benefit future animals that develop the same disease or condition as your animal.
Why are Clinical Trials Important?
Treatments being tested in Clinical Trials have been previously evaluated in a laboratory setting and promising results have supported the need for further evaluation clinically. A laboratory investigation cannot predict how a naturally occurring disease in our day-to-day environment will respond to the treatment. Many clinical trials for animals are treatments that have been proven safe and effective in humans, but have not been tested in animals with similar conditions. Since animals are different in some ways than humans, veterinary based clinical trials are needed to determine safe and effective use of these treatments for our pets.
What is Translational Research?
Clinical Trials in Translational Research apply what is learned in the laboratory setting to animals and to humans. There are advantages of studying human disease in companion animals. Companion animals, our pets, often mimic human response to disease and to effects of treatment. Clinical Trials are one way to test future human treatments that appear promising in “induced-disease” rodent models, in a body system closer to the human body.
Are Clinical Trials Voluntary?
Participation in a Clinical Trial is completely voluntary. You will be asked to review and sign a consent form that describes the trial and potential risks and benefits. The staff is available to answer your questions and concerns at any point throughout the study. You can decide to withdraw your animal from the study at any time. Please let your doctor know your concerns and they will discuss with you the best way to end your animal’s participation safely.
What are the Benefits?
There may or may not be a benefit for your animal’s enrollment in a clinical trial. Some possible benefits would include a treatment or therapy for a disease state that has few other options or a diagnostic tool that does less harm to your animal than what is currently available. Some clinical trials offer no direct benefit to the participant. Information gathered from clinical trials may help others in the future.
What are the Risks?
The experimental treatment may not be effective for your animal and may be associated with side effects. Your condition may not get better or it may get worse during a research study. There may be some unknown or rare and unforeseeable risks related to the study. These risks may include allergic reaction or an interaction with another medication. All of the known risks will be discussed with you and given to you prior to enrolling your animal in a clinical trial. To help ensure the safety of all study participants, all clinical trials performed at UF Veterinary Hospitals are approved by the Institutional Animal Care and Use Committee (IACUC) at the University of Florida. IACUC performs independent review of each research trial.
What are the Costs?
Some clinical trials are fully funded by grants from national agencies such as National Institute of Health or from contracts with agencies devoted to animal health or private companies. Other clinical trials cover specific treatments or tests that are unique to the research program and are not considered part of the regular care for your animal. The cost of participation will be discussed with you before enrolling your animal into a clinical trial.
What are my responsibilities?
- Read, understand, and sign the Informed Consent Form. The staff is available to answer any questions you may have about the research study.
- Complete the study procedures such as giving the medication on time or with-holding food as specified or completing diaries or questionnaires provided.
- Maintain scheduled appointments at the Hospital for all research related visits. Visits are often scheduled for specific time points to gather appropriate data. Please reschedule any missed appointments at the next available opportunity.
- Notify the study team if any information regarding the health of your animal or the availability to participate in the study changes. If your animal has had any medical appointments since your last visit or if you move away and will be unable to complete the scheduled visits to the study center, please let your study team know.
How to send medical records?