Frequently Asked Questions about Clinical Trials

1. What is a clinical trial?
2. Who sponsors clinical trials?
3. What are the benefits of participating in a clinical trial?
4. What are the risks of participating in a clinical trial?
5. What protections are there for people who participate in clinical trials?
6. What is informed consent?
7. Who can participate in a clinical trial?
8. What are the phases of a clinical trial?
9. What is a study visit like?
10. What should I know before I join a clinical trial?
11. How can I find out if I'm eligible for a clinical trial?
12. What if I don't qualify...where can I get help?
13. Where can I find out more about clinical trials?

What is a Clinical Trial?

The best way to scientifically evaluate the effectiveness of a treatment is to conduct a randomized controlled clinical trial. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or therapies are both safe and effective. New therapies are tested on people only after laboratory and animal studies show promising results. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces a better cure and causes fewer side effects than the other.

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Who sponsors clinical trials?

Clinical trials can be sponsored by a number of different organizations: government agencies, such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician-investigators; and health care institutions, such as health maintenance organizations (HMOs). The sponsor of a clinical trial funds the clinical trial and designs its protocol.

Find out more about participating in clinical trials in the Dallas area.

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What are the benefits of participating in a clinical trial?

There are many reasons people take part in research studies.

Often it gives you a chance to access a medicine or procedure that is not available on the market. In these cases, you should remember that the study is being performed to find out more information about the safety and efficacy of the drug or procedure. It also means that advanced diagnostic tests are readily available to ensure that patients are closely monitored and safety is assured. Depending on the phase of the clinical trial, there may be less information available about the effects of the medication than standard therapies. Often the process of collecting the information in the study may allow your doctor to find out more about your disease, which may allow you to benefit from better treatment after you have completed the trial.

Also, as a participant in a research study, you are contributing to scientific knowledge, and the information gathered will be of help to other patients with the same condition. Many people derive satisfaction from knowing that they are part of the effort to reduce the suffering of other people. Here are some other benefits:

• The treatment offered may be better and more thorough than what you may receive in private practice
• Regular laboratory tests may be conducted to monitor general medical conditions
• Your confidentiality is protected - no identifying information is shared with insurance companies or employers
• All evaluations and treatment are provided at no cost to you

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What are the risks of participating in a clinical trial?

The risks associated with participation in a clinical trial include:

• Side effects from medications, as in the case when taking many medications
• Treatment not being effective for you
• Research protocol requires a lot of your time for trips to the study site

Specific risks and benefits for each study are always described in the studies' informed consent.

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What protections are there for people who participate in clinical trials?

Doctors and other health professionals run clinical trials according to strict rules established by the Food and Drug Administration (FDA). The established rules ensure that people who agree to participate in studies are treated as safely as possible.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The sole purpose of an IRB is to protect patient rights and ensure the welfare and safety of research subjects. The board scrutinizes all trial activities including recruitment, informed consent, advertising, and potential risks. The IRB also ensures that all FDA regulations are being followed in a particular trial.

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What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:

• The study being research oriented
• The purpose of the research
• What will be done during the trial and how long the study is expected to take
• Possible risks or discomforts
• What benefits can be expected from the trial
• What other treatments are available
• Whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
• Contact information for further information about the study or for information regarding injury
• Participation being voluntary and that you have the right to leave at any time

If you are considering participating in a study, the research staff will give you informed consent documents that contain details about the study. This information should be written so you can understand it. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study or your participation before you make a decision. If you decide to participate in the trial, you must sign the informed consent form, showing that you have been given this information and understand it.

The informed consent form is NOT a contract and you can leave the study at any time, without penalty, for any reason.

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Who can participate in a clinical trial?

All clinical trials have guidelines about who can get into the program, including age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study.

The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. The main purposes of these criteria are to identify appropriate participants and to keep the trials safe. The criteria also help ensure that the researchers will be able to answer the questions they plan to study.

It is important to understand that the inclusion and exclusion criteria are not used to reject people personally, only to uphold the safety and integrity of the research study.

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What are the phases of a clinical trial?

Most clinical trails are carried out in steps called phases. Each phase is designed to find different information. Clinical trials of experimental drugs proceed through four phases:

• Phase I clinical trials are short term studies in which researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. This initial phase of testing in humans is done in healthy volunteers who usually are paid for their participation.
• Phase II clinical trials are the first studies that evaluate the treatment for the affected population and involve a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• Phase III clinical trials involve giving the study drug or treatment to large groups of people (hundreds or thousands) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. This large-scale testing often lasts several years and provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's safety, efficacy, and range of possible reactions. Once Phase III is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.
• Phase IV studies are done after the drug or treatment has been approved by the FDA. The pharmaceutical companies have several objectives in this late phase of testing: 1) to compare the drug with other drugs already in the market, 2) to monitor the drug's long-term safety, effectiveness, and impact on a patient's quality of life, and 3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. These studies may also involve different populations than those in which the drug was originally tested.

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What is a study visit like?

As a volunteer in a trial at the Mood Disorders Research Program and Clinic at UT Southwestern Medical Center at Dallas, each patient is given a thorough initial exam to diagnose their illness. The initial exams typically consist of a psychiatric evaluation, physical exam, EKG, and blood work to determine the general medical health of the patient. All study treatments are provided at no cost to the patient.

Dr. Trivedi andr Dr. Sunderajan provide day to day clinical supervision for patients evaluated by the study coordinators. They ensure the integrity and high quality of diagnostic accuracy through close supervision at the initial evaluation, both by reviewing all cases with the intake evaluator and by directly interviewing patients.

Dr. Trivedi and Dr. Sunderajan also obtain informed consent from all patients entering studies after describing the procedures and potential risks or benefits. They review all cases individually and provide a detailed follow-up clinical diagnostic interview. They also conduct a full review of systems, and review the results of ECG's and clinical laboratory results to document the general medical health of each subject.

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What should I know before I join a clinical trial?

You should know as much as possible about the research study. The informed consent will explain the details of the study. It is important for you to feel comfortable asking questions to the research staff about anything you do not understand or anything you would like more information about.

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How can I find out if I am eligible for a clinical trial?

Each trial has certain requirements for participation outlined in the research protocol.

At the Mood Disorders Research Program and Clinic, the first step is to call the intake screening line at 214-648-5249 and leave a message on the confidential voice mail. You can also fill out the online information form and indicate that you are interested in participating in a clinical trial. A study coordinator will return your call and ask a series of questions to determine if you may be a good match for one of our current studies.

If it is likely that you may qualify for a study, the coordinator will schedule an appointment for you to come to our office for a screening visit. Depending on the study, screening can take up to several hours and consists of informed consent, psychiatric and physical evaluations, and lab tests.

Follow-up visits usually take between thirty minutes and an hour.

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What if I don't qualify...where can I get help?

A coordinator can assist you by providing a list of referrals if you do not qualify for one of our studies. You can also take a look at the mental health resources listed on the Links page for more information on treatment options for mental illness or information on other clinical trials.

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Where can I find out more about clinical trials?

The Mood Disorders Research Program and Clinic staff at UT Southwestern will be happy to answer any questions you have about the study when you come in for your appointment. If you do not live in the Dallas-Fort Worth area, or if you would like more information about clinical trials, you may want to search the following websites:

• ClinicalTrials.gov: a site established by the National Institutes of Health (NIH) to provide current information about clinical research studies funded by the NIH and other federal agencies
• CenterWatch.com: an Internet resource for finding clinical trials that has email notification for current trials in the area of interest
• ClinicalTrials.com: an Internet resource for finding trials throughout the US and Canada
• Clinmark.com: an Internet resource for finding pharmaceutical clinical trials

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