Frequently Asked Questions (FAQ)
What is a clinical trial?
A clinical trial is a research study that is conducted in a medical setting such as a clinic or hospital. It usually involves the testing of a new medication, treatment, or device that is not yet approved by the Food & Drug Administration (FDA) for routine use.
The purpose of a clinical trial is to find out if a new medical treatment is safe and effective. All medications and treatments in use today were first shown to be effective in clinical trials. New and better treatments for cancer will be discovered only through the continued support of patients who participate in clinical trials.
The Department of Radiation Oncology at UT Southwestern Medical Center is a leader in developing new therapies for patients through clinical trials. It is our priority to ensure scientific integrity, privacy, safety, and ethical conduct in all clinical trials.
Who is eligible for a clinical trial?
As a patient of the Department of Radiation Oncology, you may be eligible to participate in a clinical trial. Your particular health status and disease characteristics will determine your eligibility. Patients who qualify for a clinical trial decide, with the advice of their physician, whether to participate in the study. How a treatment will work for a patient in a trial cannot be known ahead of time. Therefore, the patient should be aware of both the risks and benefits of clinical trials before making a decision.
Patients are never placed in a clinical trial without their knowledge or permission. All qualified patients involved in clinical trials sign consent forms before the study begins.
How is a clinical trial developed?
Before a new treatment is tested with patients, it is carefully studied for several years in the laboratory and tested for safety. This research identifies the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. Then, clinical trials undergo a rigorous approval process both by the FDA and by committees of UT Southwestern physicians.
One of these committees also includes patient advocates to ensure that patients are represented and that their rights are fully considered in each trial situation. Although there is always a possibility that a new treatment will be disappointing, the researchers and physicians who approve a study have reason to believe that it will be as good as, or better than, current treatments.
How can you enroll in a trial and what should you expect?
A preliminary screening visit is scheduled to discuss the details of the study with the potential volunteer and determine if he/she is eligible to participate. The nurse or physician will explain the study and the procedures you will need to follow and answer any questions you may have. This process is called informed consent and is essential before any volunteer is enrolled in any clinical trial. In addition, a full medical history is obtained and a physical exam and lab testing are done to make sure there are no contraindications for your participation in the clinical trial. All clinical trials require a time commitment and study schedules vary depending on the individual study.
What information do you need to decide whether or not to enroll in a trial?
Patients should be informed about:
- The purpose of the study
- The length of the study and what procedures will be done as part of the research study
- Potential risks or discomforts that may be associated with these procedures, including additional treatment costs, if any
- What other treatments are available should you not decide to participate in the study
Are investigational treatments better than currently available ones? Are they safe?
Clinical trials are done with the hope that the new treatment will be as (or more) effective than currently available treatments, but this is not known. By definition, if we are doing a study, it is because we do not know if it is more effective, and there is a chance that it will be less effective than current treatment. Similarly, clinical trials are designed with safety in mind, and known risks are explained in the consent form. However, there may be risks that are not known at the time the study is started.
What are the rights of a clinical trial volunteer?
- You will be adequately informed of the study and be given a chance to ask any questions
- Participation in any clinical trial is voluntary
- Any information obtained in a clinical trial remains confidential and is shared only with those involved in the study unless authorized by the participant. Just like any other medical record, a research record may be inspected by the FDA, other federal regulatory authorities, and other legally authorized parties.
How do I sign up for a clinical trial?
Call our clinical trials information line at 214-645-7322.