Clinical Trials

Go To: Clinical trials at UNTHSC | What is a clinical trial? | Are clinical trials safe? | Why participate?| To volunteer |Current and future studies

The University of North Texas Health Science Center's Office of Clinical Trials is one of hundreds of sites across the United States committed to proving the effectiveness and safety of new treatments for today's diseases and disorders. Our office conducts more than 20 clinical studies each year for some of the nation's leading pharmaceutical companies. It is our hope you will see the benefit of being part of a clinical study, and realize how your participation may have the potential to benefit the lives of millions of other people dealing with your same medical condition.

What is a clinical trial?

A clinical trial is a form of clinical research. Specifically, it is a carefully designed study of a potential new drug, medical treatment or medical device on a group of patients. Most clinical trials are funded by the manufacturer of the drug or the device being tested. After a great deal of laboratory testing, drugs must pass three phases of clinical trials to be approved by the Food and Drug Administration (FDA).

Following thorough testing in a scientific laboratory setting, a drug will then be sent to a clinical research lab to be studied for treatment of a specific medical condition.

Clinical studies of a drug, called clinical trials, rely on a small group of people with the specific medical condition who volunteer to test the drug under close supervision of a doctor. Through clinical trials, doctors are able to test how safe and effective a drug is, determine what dose works best and recognize what side effects, if any, it causes.

Here is what happens at each phase:

Phase One. Studies at this initial phase are mainly concerned with assessing a drug's safety. Drugs are given to a small number of healthy volunteers to see what happens to the drug in the human body and to check for side effects.

Phase Two. A phase two study provides information about how effective and safe a drug is. If a drug has been shown safe at phase one, it will likely go into phase two testing, which may involve small numbers of patients who have the disease for which the drug is being tested. To participate in the trial at this point, patients may have to meet strict criteria or guidelines. For example, a trial testing a new drug for rheumatoid arthritis might require that participants have been diagnosed with the disorder in the previous six months and that they haven't taken any drugs that might modify or change the disease.

Phase Three. This phase, which may last a few years, provides the FDA and the drug company with more information about how effective a drug is and about any adverse reactions. At this phase a drug is tested on larger numbers of patients who meet strict criteria or guidelines.

Once a drug passes phase three testing, a company may pursue approval from the FDA for use with a particular disease or illness. Even after a drug is approved and marketed, however, studies often continue. Late phase three/phase four studies may be used to evaluate a drug's long-term effect, or to compare the drug to others on the market.

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Are clinical trials safe?

Clinical trials follow a strict protocol, or plan, that spells out exactly how the research will be performed. The protocol dictates the dosage of study medicine patients receive, how often they must come for a check up, and which type of testing is necessary to watch for side effects.

The FDA requires that all participants give 'informed consent' before treatment, meaning that all possible known risks to your health, potential benefits from the drug, and alternatives to the study must be discussed with you. An Institutional Review Board, composed of doctors, scientists and members of the community, will examines each study's protocol or plan to ensure the study does not pose an unnecessary risk to participants.

You may also stop participating in the study at any time and for any reason if you are not comfortable with taking the study medicine.

As a participant you must realize, however, that in some studies you have a 50-50 chance of getting a placebo rather than the study drug. A placebo is an inactive substance that does not contain any medicine. If the drug proves to be effective, study participants are often given the option of taking the drug at the end of the study.

Because you will be taking a drug that hasn't been widely used or used long-term, you must understand that the risk of side effects is still uncertain. Also, participating in a clinical trial may require you to stop taking a drug that has been helping you.

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Why participate?

Clinical studies offer you the opportunity to contribute to the understanding of disease or its treatment. This may not directly affect you or your care, but will give you the satisfaction of knowing you may have helped improve lives of future generations. Without research volunteers, new therapies could not be developed and new drugs would never be approved by the FDA.

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To volunteer

To find out how you can volunteer to participate in a clinical trial, or to express an interest in studies for a certain medical condition, call the Office for Clinical Trials at (817) 735-0256. You will be under no obligation if you qualify for enrollment into a study. You may withdraw at any time. We encourage you to speak with your doctor or a doctor at our facility to learn more about how a clinical trial may benefit you.

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Current studies

Cholesterol Clinical Trial- Internal Medicine Department

The Internal Medicine Clinic is conducting a research study with an investigational cholesterol lowering medication. We are looking for volunteers age 55 and older, male and female with normal cholesterol. All study visits, blood tests, and study medication will be at no cost to the volunteer. Interested participants should call the study coordinator at 817-735-5159.

Diabetes Prevention - Volunteers Needed

We are participating in the largest Diabetes prevention trial ever, with over 7500 people taking part in over 40 countries. The research program will evaluate two medications, currently FDA approved for other uses to determine whether they safely and effectively delay the onset of type 2 diabetes and cardiovascular events such as heart attack and stroke.
If you or someone you know are at least 50 years old and have some of the common risk factors for developing diabetes please call 817- 735- 5159 for more information.

Risk factors include :Family history of diabetes or early heart disease, high blood pressure, high cholesterol, current cigarette smoking,overweight,and previous heart attack or stroke.

All study visits are provided (at no charge) to those who take part. Diet counseling is included also.

Dementia Clinical Trials - Study Volunteers Needed

Study 1:
A 6 month research study on the treatment of Alzheimer's disease. Volunteers must have a diagnosis of mild to moderate dementia of the Alzheimer's type and be in good physical health. A series of memory tests will be done at each visit. Lab work and EKG's will also be done at specified times. A reliable caregiver must accompany the person to every visit.

Study 2:
A 6 month research study on an FDA approved medication to treat dementia of the vascular type. This study is looking at treating dementia caused by strokes. Volunteers must have a diagnosis of vascular dementia in the mild to moderate stages and be in good physical health. A series of memory tests, lab work and EKG's will be done at scheduled visits. A reliable caregiver must accompany the person to every visit.

Study 3:
A 6 month research study for persons diagnosed with mild to moderate dementia of the Alzheimer's type who are on the medication Aricept . This study looks at combining Aricept with Vitamin E to improve thinking ability. A series of memory tests are done at scheduled visits - all person enrolled in study will be provided Aricept for the duration of the study.

Volunteers will receive physical exams, neuropsychological testing, study medications and medical procedures at no cost. For more information contact Barbara Harty, MSN at 817-735-2193.

Osteoarthritis Clinical Trial - Division of Rheumatology

Volunteers are needed by the Division of Rheumatology, for an Osteoarthritis clinical trial. Potential study participants with a diagnosis of Primary Osteoarthritis of the knee(s), hip(s), spine, neck, lower back or hand(s) must be at least 50 years of age or older, be taking medication for osteoarthritis, and rate pain at least moderate when not on medication.
If you would like more information, please contact Cynthia Jimenez-Williams R.N. at (817)735-0317.

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