What Is a Clinical Trial?
A clinical trial is a research program conducted with arthritis patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating different diseases and special conditions.
Clinical trials make it possible to apply the latest scientific and technological advances in arthritis to patient care. During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are considered to be at least as effective or possibly more effective than the standard.
New arthritis treatment options are first researched in the lab where they are carefully studied in the test tube and in laboratory animals. Only the treatments most likely to work are further evaluated in a small group of people prior to applying them in a larger clinical trial.
When a new medical treatment is studied for the first time in people, it is not known exactly how it will work. With any new treatment, there are possible risks as well as benefits. Clinical trials help doctors determine:
- If the treatment is safe and effective
- If the treatment is potentially better than the treatments currently available
- If the treatment causes side effects
- If the treatment carries potential risks
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 their overall condition. Most clinical trial participants take part in phases III and IV.
What Are the Different Phases of a Clinical Trial?
In a phase I clinical trial, the new arthritis treatment being investigated 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 effect of an experimental treatment on the particular disease or condition being evaluated. The best dosage is usually determined during this phase, as well.
Phase III clinical trials compare the new treatment with standard arthritis treatments.
Phase IV clinical trials apply the new treatment to general patient care. For example, a new drug that was found effective in a clinical trial may be used together with other effective drugs to treat the particular disease or condition in a select group of patients.
Advantages and Disadvantages of Participating in a Clinical Trial
The advantages of participating in a clinical trial include:
- You may receive a new arthritis treatment before it is widely available to the public.
- You can provide researchers with the information they need to continue developing new procedures and introducing new treatments.
- Your arthritis 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 before joining a trial.
The disadvantages include:
- All of the risks and side effects of the treatment being researched are not known at the beginning of the clinical trial. Since this is the case, there may be unknown side effects (as well as hoped-for benefits). Participants will be informed of any known, possible side effects as well as any "new" side effects that occur or become known while they are participating in the trial.
How Would Arthritis Treatment Differ If I Participate in a Clinical Trial?
If you are participating in a clinical trial:
- You may receive more exams and tests than are usually given for your arthritis. 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.
- Some clinical trials are double-blind, placebo-controlled. This means that the clinical trial participants may receive the real drug or an inactive substance that looks exactly like the drug (called a placebo). Neither the participant nor the researcher will know which drug they are receiving. This is done to make certain that the real drug is effective.
Keep in mind that participating in a clinical trial is voluntary. Even though your doctor may advise you to take part in a clinical trial, it is up to you to make the ultimate decision.
If you decide to participate in a trial, you will be asked to give informed consent. This 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 doctor or nurse to explain parts of the form or the trial that are not clear.
You are free to decide whether 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 arthritis 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 for arthritis.
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 your acceptability as a candidate.
I'm Nervous About Participating In a Clinical Trial. Should I Be?
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 arthritis 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 arthritis treatments are given -- in clinics or a doctor's office.
- Clinical trial participants are watched closely, and information about you will be carefully recorded and reviewed.
Important Questions to Ask About a Clinical Trial
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, and how are these tests given?
- What is likely to happen in my case with, or without, this new research treatment? (Are there standard arthritis treatment options for my situation, and how does the study compare with them?)
- How could the clinical trial affect my daily life?
- What side effects can I expect from the experimental treatment?
- How long will the clinical trial last?
- Will the clinical trial require extra time on my part?
- Will I have to be hospitalized? If so, how often and for how long?
- If I withdraw from the clinical trial, will my arthritis care be affected? Will I need to change doctors?