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UT Southwestern is committed to providing the highest level of care for patients. To develop innovative new treatments, improve diagnosis, and help prevent diseases, our teams conduct clinical studies and clinical trials. Patients with specific diseases or conditions as well as healthy individuals can contribute greatly to our research.
The treatment you receive today is available only because someone volunteered in the past to participate in a study. If you have the opportunity to participate in a clinical study or trial, we hope you will consider it.
Below, we invite you to learn more about clinical studies and search our database for clinical trials that are currently enrolling patients.
While we often use the term “clinical trial” because it is most familiar to patients, it’s important to define several of the terms associated with research so you understand the differences when you’re discussing them with your health care team.
A clinical study (or clinical research) is medical research involving people. The purpose is to uncover better ways to diagnose, treat, prevent, and understand human disease. People volunteer to participate in clinical studies.
These studies test an intervention (sometimes a treatment), but usually a:
Example: A study that tests whether a new drug works as well as the current drug in the treatment of cancer.
Observational studies collect health information about study participants without changing their medical care. Unlike interventional trials, the researcher does not assign participants to a specific treatment or procedure.
Example: Researchers observe a group of older adults to learn more about the effects of different lifestyles on heart health. Researchers collect a tube of blood to run tests, but do not take any action with participants on the results. The blood is being used for research purposes only.
Clinical trials have four phases, or steps, in the clinical research process. You may notice when you see a name of a clinical trial that it includes Phase I, II, III, or IV, or it may be written as Phase 1, 2, 3, or 4. Here’s what those phases mean:
Researchers test a drug or treatment in a small group of people (20-100) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
The new drug or treatment is given to a larger group of people (100-300) to determine its effectiveness and to further study its safety.
The new drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment's benefits, and optimal use.
Participation in a clinical study means you have volunteered to enroll in that study. Participation in a clinical study is always voluntary, meaning participants can leave a study at any time.
At UT Southwestern, we need both healthy participants and patients for various types of studies.
Different people have different reasons for becoming a research participant. Here are common reasons why people choose to take part in research studies:
Here’s what happens before and after you enroll in a clinical study or clinical trial.
For trials enrolling patients with a particular medical condition, some pre-screening may happen behind-the-scenes before we meet with you. For studies enrolling healthy volunteers, staff members explain the trial in detail and gather more information about you during the prescreening process.
Informed consent is an essential part of participating in a clinical study. It is the process of learning the key facts about a clinical study before deciding whether to participate. Once you have had all your questions answered, and if you agree to participate, you may be asked to sign an informed consent form. Participants should take the time to review the informed consent document carefully and decide if they feel comfortable with participating in the study.
You will get a copy of the document, which you can keep to refer back to in the future. Also, note that informed consent is a continuous process that does not end with a signed document. You should always feel free to ask questions about your participation in a study at any time during or after your participation ends. The researchers will also provide you any new information during the study if it could affect your willingness to participate.
Once you have consented to participate in a study, you may be asked to undergo other procedures and tests, such as filling out questionnaires or having blood work, to confirm that you qualify for the study. You may be asked to make a special visit for screening.
Once you have enrolled, the study team will review the study procedures with you and schedule tests and other appointments. You will follow the trial procedures and report any issues or concerns to the study team. Remember, participating in a clinical study is totally voluntary and you can decide to stop at any time. Study participants continue to see their regular physician for usual health care throughout the study.
Your participation in the study is complete. Researchers may provide participants with information about how they may find results once the study data is analyzed.
Protections are in place to ensure that each study is as safe as possible, but these methods of protection do not eliminate all possibility of risk. Institutional Review Boards (IRBs) oversee all clinical studies at UT Southwestern. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical studies are ethical and that the rights and well-being of participants are protected.
Informed consent is an essential part of participating in a clinical study. It is the process of learning the key facts about the clinical study before deciding whether to participate.
If someone is interested in participating in a study, the research team may provide an informed consent document that includes details about the study, such as its purpose, how long it lasts, required procedures, potential risks, and whom to contact with questions or issues.
It is the responsibility of the research staff to help participants understand the information about the study and give them time to decide if they want to participate. Participants should feel comfortable asking questions and discussing with the research team any concerns they might have.
The process of informed consent does not end when someone signs the informed consent document. It is a process that continues with ongoing conversations between the research team and participants before, during, and after research participation. If someone decides they no longer want to participate in the study, they can withdraw at any time.
Clinical studies allow scientists and researchers to answer specific questions about the effectiveness and safety of drugs, vaccines, devices, and treatments. In order to obtain comprehensive data, research studies require diverse participants. This is especially important for certain populations, such as adults aged 75 years or older, people from different ethnic and racial groups, people from different socioeconomic backgrounds, and other underrepresented communities such as LGBTQ and persons with disabilities.
The U.S. Food and Drug Administration (FDA) explicitly states the importance of diversity in clinical studies:
UT Southwestern is committed to creating a diverse environment for research participants and their families. We strive to include all racial and ethnic groups, different sexual orientations/genders, and various age groups into our clinical studies. Our ultimate goal is to ensure your health condition and background are represented.
As a UT Southwestern patient, you may be contacted for possible participation in a clinical study or clinical trial based on your diagnosis or medical history. It will be your choice to move forward with participation or not.
If you do not wish to be contacted about clinical studies, please let us know in one of the following ways:
Please note that even if you opt-out of contact, your physician or care team may still discuss clinical trial opportunities with you.
As we continue to improve with simpler, more useful, and engaging content, we welcome your comments and suggestions for how we can make this Clinical Trials page a better resource for you.