Clinical trials are research studies that involve people. The main purpose of a clinical trial is to find a better way to prevent, diagnose or treat a disease. Clinical trials are part of a long, careful research process. Patients who participate in a clinical trial receive drugs or procedures that already have been researched in successful laboratory and/or animal studies. Most clinical trials study new drugs or procedures, but some study drugs or procedures that have already received approval by the U.S. Food and Drug Administration.

All patients who participate in clinical trials are volunteers. They can choose to stop their participation in a clinical trial at any time.

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Why are clinical trials important?
Clinical trials are important to develop new treatments to prevent,diagnose, or treat a disease. Many of today’s standard of care treatments are based on the results of previous clinical trials.

What are the types of clinical trials?

Therapeutic trials test new drugs, surgery techniques, therapy procedures or other treatment methods.

Prevention trials study how healthy people may disease. People at high risk of a certain ailment or disease may benefit from participation in a prevention trial.  

Early-detection/screening trials discover ways to find early-stage ailment or disease. 

Diagnostic trials find new and better ways to determine if someone has an ailment or disease.

Quality of life/supportive care trials seek to improve the comfort and quality of life of patients and their families or caregivers.

For more information about other types of clinical trials, please consult your doctor.

How does UT Southwestern protect patients?
When conducting clinical trials, UT Southwestern’s most important responsibility is to protect patients through well-designed protocols,
a dedicated Institutional Review Board (IRB) and a careful informed consent process.

Clinical Trial Protocol
A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by UT Southwestern’s Institutional Review Board (IRB).

If you have questions or concerns about safety while participating in a clinical trial, please contact a member of your clinical trial team. If you still have questions about the study or your rights as a participant, contact the Institutional Review Board (IRB) at (214) 648-3060.

The Institutional Review Board

UT Southwestern has four Institutional Review Boards (IRBs). An IRB is a committee of people, such as doctors, nurses, scientists, dentists, chaplains, social workers, attorneys and patients who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.

Before a clinical trial can begin, the IRB reviews and approves the protocol to make sure that it is based on reliable scientific evidence. The IRB attempts to ensure that the protocol will not cause excessive harm to any patient.

After a clinical trial begins, the IRB monitors the trial at least once a year and stops it if any safety concerns arise. For example, if a patient developed dangerous side effects, then the trial would be stopped. It also may stop a clinical trial early if it becomes clear that the new treatment is much more effective than standard treatment, so that all participants may receive the better treatment.

The FDA regulates UT Southwestern IRBs by auditing IRB minutes, staff and facilities every five years. FDA officials also can visit UT Southwestern at any time and review anything they choose related to clinical trials. 

The Informed Consent Process
If you have the option to participate in a clinical trial, you will go through a process called informed consent. You will learn details about a specific clinical trial so that you may decide whether to participate. The informed consent process protects patients by ensuring that they understand the clinical trial’s plan before agreeing to participate.

The researcher or nurse from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits.

You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may be helpful by listening to the explanation, asking questions and recording answers. Some doctors encourage patients to bring tape recorders so they can review the information afterwards.

You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.

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