You may have heard about clinical trials from your doctor, read or heard advertisements in the newspaper or on the radio, or found out about trials in your area through a support group or association. Before you decide to participate in a trial, you should be aware of the potential benefits and risks. This guide provides a brief overview of the clinical trial process.
What Is a Clinical Trial?
A clinical trial is a research program conducted with patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating diseases and special conditions.
During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are hoped to be at least as effective as -- or possibly more effective than -- the standard.
New treatment options are first researched in the laboratory, where they are carefully studied in the test tube and in animals. Only the treatments most likely to work are further evaluated in a small group of humans prior to applying them in a larger clinical trial.
When a new medical treatment is studied for the first time in humans, scientists don't know exactly how it will work. With any new treatment, there are possible risks as well as benefits. Clinical trials help doctors discover the answers to these questions:
- Is the treatment safe and effective?
- Is the treatment potentially better than the treatments currently available?
- What are the side effects of the treatment?
- Does the treatment have any possible risks?
- How well does the treatment work?
How Does the Clinical Trial Process Work?
Clinical trials are conducted in phases -- each designed to find out specific information. Each new phase of a clinical trial builds on information from previous phases.
Participants may be eligible for clinical trials in different phases, depending on the participants' overall condition. Most clinical trial participants take part in phases III and IV.
In a phase I clinical trial, a new research treatment is given to a small number of participants. The researchers determine the best way to give the new treatment and how much of it can be given safely.
Phase II clinical trials determine the effectiveness of the research treatment on the disease or condition being evaluated.
Phase III clinical trials compare the new treatment with the standard treatment.
Phase IV clinical trials apply the new treatment to patient care. For example, a new drug that was found effective in a clinical trial may then be used together with other effective drugs to treat the particular disease or special condition in a select group of patients.
What Are the Advantages of Participating in a Clinical Trial?
The advantages of participating in a clinical trial include the following:
- Clinical trials make it possible to apply the latest scientific and technological advances to patient care.
- You may receive a new treatment before it is widely available to the public.
- You can help to provide researchers with information they need to continue developing new procedures and introducing new treatment methods, for your benefit and to benefit others.
- Your treatment costs may be decreased, since many of the tests and doctor visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. Be sure to discuss your treatment costs with the doctors and nurses conducting the clinical trial.
What Are the Disadvantages of Participating in a Clinical Trial?
- Because the drug or device being studied is new, all of the risks and side effects of the treatment are not known at the beginning of the clinical trial. There may be unknown side effects (as well as hoped-for benefits). Patients will be informed of any known side effects they could experience, as well as any side effects that occur or become known while they are participating in the trial.
- It is also important that you realize that if you participate in a clinical trial you may be given a placebo, which is a sugar pill containing no medicine. These tablets are used to determine if the real treatment is really working effectively. Trials are conducted in such a way that you will not be told if you're getting the real treatment or a "fake" treatment.
How Would my Care Be Different if I Participated in a Clinical Trial?
- You may receive more exams and tests than are usually given for your particular condition. The purpose of these tests is to follow your progress and collect study data. Of course, tests can carry certain benefits and risks or discomforts of their own. Although they can be inconvenient, these tests can assure extra observation.
- Depending on the type of clinical trial, you may be asked to stop or change the medication(s) you are currently taking. You may also be asked to change your diet or any activities that could affect the outcome of the trial.
- As mentioned above, you could get the placebo rather than the real medicine.
What Is Informed Consent?
Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.
You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the researchers to explain parts of the form or the trial that are not clear. (See "Important Questions to Ask" below.)
You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
Who Can Participate in a Clinical Trial?
Every clinical trial is designed to meet a specific set of research criteria. Each study enrolls patients with certain conditions and symptoms. If you fit the guidelines for a trial, you may be able to participate. In some instances, you may be required to undergo certain tests to confirm that you are eligible.
What Is It Like to Participate in a Clinical Trial?
All patients face a new world of medical terms and procedures. Fears and myths of being experimented upon or being a guinea pig are common concerns of patients who are thinking about participating in a clinical trial.
Even though there are always going to be fears of the unknown, understanding what is involved in a clinical trial before agreeing to participate can relieve some of your anxieties.
This may help ease your concerns:
- The personal information gathered about you during the clinical trial will remain confidential and will not be reported with your name attached.
- If at any time throughout the trial you and your doctor feel it is in your best interest to exit the trial and use other known treatments, you will be free to do so. This will not in any way affect your future treatment.
- Clinical trial participants typically receive their care in the same places that the standard treatments are given -- in clinics or doctor's offices.
- Clinical trial participants are watched closely, and information about you will be carefully recorded and reviewed.
Important Questions to Ask
If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to participate. Here are some important questions to ask:
- What is the purpose of the clinical trial?
- What kinds of tests and treatments does the clinical trial involve?
- How are these tests administered?
- What is likely to happen in my case with, or without, this new research treatment? (Are there standard treatment options in my case, and how does the study treatment compare with them?)
- How could the clinical trial affect my daily life?
- What side effects can I expect from the clinical trial?
- How long will the clinical trial last?
- Will the clinical trial require me to give up some of my personal time? If so, how much?
- Will I have to be hospitalized? If so, how often and for how long?
- If I agree to withdraw from the clinical trial, will my care be affected? Will I need to change doctors?
- If the treatment works for me, can I continue taking it after the trial?