Clinical Trials and Research Studies

Clinical Studies at UTMB

A Clinical Trial is a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, biologics, treatments, devices, or new ways of using known drugs, biologics, treatments, or devices). Behavioral interventions are intended to prevent or treat an acute or chronic disease or condition.

Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

You can check the UTMB Clinical Study Listings to find some of the studies enrolling study participants.


ResearchMatch_logo

ResearchMatch

ResearchMatch.org is a national web-based registry of individuals interested in research studies. It is a free and secure tool to help match willing volunteers with eligible researchers and their studies at participating Clinical Translational Sciences Award (CTSA) institutions across the U.S.

Should You Participate in Clinical Research?

People participate in clinical research for a variety of reasons. People who volunteer for clinical trials may gain access to promising drugs before these compounds are approved by the Food and Drug Administration for the marketplace. Others choose to participate as a way to advance science.

What is a Clinical Trial?

A clinical trial or study is a scientific test of the effectiveness and safety of a therapeutic intervention (such as a drug, surgery, procedure, device, or vaccine) using consenting human subjects. Clinical trials can also test new uses of drugs or treatments that are already approved by the Food and Drug Administration for a specific use. Clinical trials are carried out under strict guidelines with great attention to measures of safety.

As a patient, your rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the Federal Government must obtain approval to conduct the study from an Institutional Review Board (IRB). The IRB, which is usually composed of physicians from different specialties as well as people with no formal science training, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States signs an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.

Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted . The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

What are the benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks

    There are risks to clinical trials.

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

What are the different types of clinical trials?

  • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

About Informed Consent

Informed consent is a process by which participants learn the important facts about a clinical trial to help them decide whether to participate.

This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study.

Questions to ask the Study Coordinator or Physician include:   

  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and how? What is the main purpose of the trial?
  • How will patient safety be monitored? Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested in the trial?
  • Who is sponsoring the trial?
  • Do I have to pay for any part of the trial?
  • What happens if I am harmed by the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?
  • What happens to me when the study is over?

UTMB Trials Today

Current Clinical Trials Accepting Volunteers

UTMB Trial Resources

Clinical Trial Resources

The web sites described below may be of interest. You can follow the link to these sites by clicking on the site's emblem in the left sidebar or down below in the description.

  • ResearchMatch.org is the national clinical research recruitment registry for volunteers wanting to find out about and possibly participate in clinical research studies.
  • CISCRP  is the Center for Information and Study on Clinical Research Participation for study participants and researchers.
  • Medline Plus is a trusted resource for health and medical information, medical dictionaries, tutorials and more from the National Library of Medicine.
  • ClinicalTrials.gov is a good source for learning about clinical trials and results of trials conducted in the U.S. and other countries.

When you are ready, search the study listings at UTMB. 

If you have a particular interest and do not see any studies listed, or have questions, please email clinical.research@utmb.edu for more information.