The UNT Health Science Center’s Office of Clinical Trials is one of hundreds of sites across the United States committed to proving the effectiveness and safety of new treatments for today’s diseases and disorders. Our office conducts more than 20 clinical studies each year for some of the nation’s leading pharmaceutical companies. It is our hope you will see the benefit of being part of a clinical study, and realize how your participation may have the potential to benefit the lives of millions of other people dealing with your same medical condition.
What is a clinical trial?
A clinical trial is a form of clinical research. Specifically, it is a carefully designed study of a potential new drug, medical treatment or medical device on a group of patients. Most clinical trials are funded by the manufacturer of the drug or the device being tested. After a great deal of laboratory testing, drugs must pass three phases of clinical trials to be approved by the Food and Drug Administration (FDA).
Following thorough testing in a scientific laboratory setting, a drug will then be sent to a clinical research lab to be studied for treatment of a specific medical condition.
Clinical studies of a drug, called clinical trials, rely on a small group of people with the specific medical condition who volunteer to test the drug under close supervision of a doctor. Through clinical trials, doctors are able to test how safe and effective a drug is, determine what dose works best and recognize what side effects, if any, it causes.
Here is what happens at each phase:
- Phase One: Studies at this initial phase are mainly concerned with assessing a drug’s safety. Drugs are given to a small number of healthy volunteers to see what happens to the drug in the human body and to check for side effects.
- Phase Two: A phase two study provides information about how effective and safe a drug is. If a drug has been shown safe at phase one, it will likely go into phase two testing, which may involve small numbers of patients who have the disease for which the drug is being tested. To participate in the trial at this point, patients may have to meet strict criteria or guidelines. For example, a trial testing a new drug for rheumatoid arthritis might require that participants have been diagnosed with the disorder in the previous six months and that they haven’t taken any drugs that might modify or change the disease.
- Phase Three: This phase, which may last a few years, provides the FDA and the drug company with more information about how effective a drug is and about any adverse reactions. At this phase a drug is tested on larger numbers of patients who meet strict criteria or guidelines.Once a drug passes phase three testing, a company may pursue approval from the FDA for use with a particular disease or illness. Even after a drug is approved and marketed, however, studies often continue. Late phase three/phase four studies may be used to evaluate a drug’s long-term effect, or to compare the drug to others on the market.
Are clinical trials safe?
Clinical trials follow a strict protocol, or plan, that spells out exactly how the research will be performed. The protocol dictates the dosage of study medicine patients receive, how often they must come for a check up, and which type of testing is necessary to watch for side effects.
The FDA requires that all participants give ‘informed consent’ before treatment, meaning that all possible known risks to your health, potential benefits from the drug, and alternatives to the study must be discussed with you. An Institutional Review Board, composed of doctors, scientists and members of the community, will examines each study’s protocol or plan to ensure the study does not pose an unnecessary risk to participants.
You may also stop participating in the study at any time and for any reason if you are not comfortable with taking the study medicine.
As a participant you must realize, however, that in some studies you have a 50-50 chance of getting a placebo rather than the study drug. A placebo is an inactive substance that does not contain any medicine. If the drug proves to be effective, study participants are often given the option of taking the drug at the end of the study.
Because you will be taking a drug that hasn’t been widely used or used long-term, you must understand that the risk of side effects is still uncertain. Also, participating in a clinical trial may require you to stop taking a drug that has been helping you.
Clinical studies offer you the opportunity to contribute to the understanding of disease or its treatment. This may not directly affect you or your care, but will give you the satisfaction of knowing you may have helped improve lives of future generations. Without research volunteers, new therapies could not be developed and new drugs would never be approved by the FDA.
To find out how you can volunteer to participate in a clinical trial, or to express an interest in studies for a certain medical condition, call the Office for Clinical Trials at (817) 735-2586. You will be under no obligation if you qualify for enrollment into a study. You may withdraw at any time. We encourage you to speak with your doctor or a doctor at our facility to learn more about how a clinical trial may benefit you.
Office of Clinical Trials
1000 Montgomery St.
Fort. Worth, TX. 76107-2699