Patient Resources

Clinical Trials

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UT Southwestern is committed to providing excellent and innovative care for our patients. Staying on the cutting edge of medicine requires research to help us advance and change the standard of care. To develop new treatments, improve diagnosis, and help prevent diseases, UT Southwestern conducts clinical studies and clinical trials to add to existing knowledge about diseases and conditions.

This type of clinical research depends on people like you. 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.

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Understanding Clinical Studies and Clinical Trials

Important Terms

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.

There are two types of clinical studies:

1. Interventional Clinical Trials

These studies test an intervention (sometimes a treatment), but usually a:

  • Medical product, drug, or device
  • Procedure, such as a new measure to prevent falls
  • Change to participants' behavior, such as diet

Example: A study that tests whether a new drug works as well as the current drug in the treatment of cancer.

2. Observational Studies

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.

Study Phases

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:

Phase 1

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.

Phase 2

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.

Phase 3

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.

Phase 4

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.

What Does It Mean to Participate?

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.

Why Should I Participate?

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:

  • Help improve treatment for others in the future suffering with the same condition
  • Make a difference to society
  • Improve their own health
  • Access cutting-edge treatment options that might not be available outside the research setting

What Can I Expect?

Here’s what happens before and after you enroll in a clinical study or clinical trial.

Clinical Study or Clinical Trial Steps

Prescreening

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

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.

Screening Visit

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.

Enrollment and Participation

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.

End of 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 for Study Participants

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.

More About Informed Consent

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.

Representation: Importance of Diversity in Clinical Research Studies

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:

  • Certain populations can be more at risk for certain diseases – such as diabetes and heart disease – than others. It is important for patients in those populations who are more likely to be treated for a condition to be included in a trial.
  • Experience has shown that there can be important differences in how people of diverse groups respond to medical products. Information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.

Be Represented

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.

Questions to Ask Before Participating in a Clinical Study

Questions About the Clinical Study
  • What is the research about and why is it being done?
  • What do researchers hope to learn and who might benefit from it?
  • What kind of study is this?
    • Is it a clinical trial?
    • How many groups (or arms) are there?
    • Is assignment to groups randomized, or can I choose?
    • Will any of the groups receive a placebo or an inactive treatment?
  • How will the findings of the research be shared and will I be informed personally?
  • Who has reviewed and approved the study?
  • When is the study expected to be completed?
  • Who is funding the study?
Questions About Risks and Possible Benefits
  • What are the risks of the research intervention? Does the intervention have FDA approval or oversight?
  • What are the short- or long-term risks, discomforts, or unpleasant side effects?
  • How are the researchers minimizing risks, discomforts, or unpleasant side effects?
  • Is there anything I can do to minimize my risks during the study?
  • Will I, personally, benefit from participating in the research? If so, how?
Questions About Participation and Care
  • Why am I, specifically, being asked to participate?
  • Who is being asked to volunteer for the study?
  • What is my role? What kind of medications, procedures, or tests will be done?
  • Will I have to go anywhere to participate in the study?
  • Do I have adequate time to participate in this study?
  • Will I be given the results of any study tests or procedures that are done?
  • If I choose not to participate, what treatments or procedures are available to me?
  • If my doctor is also a researcher in the study, who will watch out for my best interests as a participant? If I decide not to participate, will the decision affect my current medical care?
  • How will being in this study affect my daily life?
  • How will being in this study affect my current medical care?
  • Can I talk to other people in the study?
  • Whom should I contact if I have questions about participating in the research?
Questions About Privacy and Confidentiality
  • How will my biological materials (such as blood samples), data (such as test results), or other personal information be used or shared?
  • How will my privacy and identifiable private information be protected?
  • What could happen to me if my identifiable private information is disclosed to others?
Questions About Cost
  • Will I have to pay for any part of the trial, such as tests or study medications? If so, what will the charges likely be?
  • Do clinical studies bill insurance?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be any travel or child care costs that I need to consider while I am in the trial?

Being Contacted for Participation in Research

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:

  • Notify staff during check in at your next UT Southwestern doctor’s appointment
  • Log in to UT Southwestern MyChart: You’ll find participation preferences under Medical Record > Medical Tools > Research Studies
  • Email us at researchregistry@utsouthwestern.edu
  • Call us at 214-648-5055
  • Write us at UTSW Research Registry, 5323 Harry Hines Blvd., Dallas, TX 75390-8592 and provide your full name, address, and date of birth.

Please note that even if you opt-out of contact, your physician or care team may still discuss clinical trial opportunities with you.

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