A clinical trial is a research study conducted with patients to evaluate a new arthritis treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating arthritis.
Arthritis Research Starts in the Laboratory
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 arthritis 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 treatment options are first researched in a 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 arthritis treatment is studied for the first time in humans, 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 discover the answers to the following 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?
Phases of a Clinical Trial
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.
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 the research treatment on patients and usually the best dosage.
In phase III clinical trials, the drug or treatment is given to large groups of people 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
Phase IV clinical trials apply the new treatment to patient care. Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Advantages and Disadvantages of Clinical Trials
The advantages of participating in a clinical trial include the following:
- 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 treatment methods.
- 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.
Potential side effects from participating in a clinical trial will depend on the type of treatment and the patient's condition.
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. It's important to note that most arthritis treatments -- as well as the disease or condition itself -- have potential side effects.
Patients 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.
Clinical Trial Treatment
There are some differences in receiving arthritis treatment in a clinical trial vs. receiving regular treatment. 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 an extra ounce of observation along the way.
Depending on the type of clinical trial you are participating in, you may be asked to stop or change medications you are currently taking. You may also be asked to change your diet or any activities that may 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 doctor will know which drug the patient is receiving. This is done to make certain that the real drug is effective.
Clinical trial participants are willing volunteers. Even though patients may be asked by their doctors to take part in a clinical trial, it is up to each patient to make the final decision.
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 doctor or nurse to explain parts of the form or the trial that are not clear.
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 to sign the consent form. 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.
Clinical Trial Participation
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 acceptance.
Every patient faces a new world of medical terms and procedures. Fears and myths of "experimentation" or "being a guinea pig" are common concerns of arthritis 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. Here's some information that 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 during the trial your doctor feels 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 arthritis treatment.
- Clinical trial participants typically receive their care in the same places that the standard arthritis treatments are given -- in clinics or doctors' offices.
- Clinical trial participants will be watched closely and data on their case 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?
- How are these tests given?
- What is likely to happen in my case with, or without, this new research treatment? Are there standard treatment options for my arthritis, 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? (Note: There can also be side effects from standard arthritis treatments and from the disease itself.)
- 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 agree to withdraw from the clinical trial, will my care be affected? Will I need to change doctors?