Arthritis Studies: A Guide for Patients

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 inarthritis 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 laboratory 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
• What the side effects of the treatment are
• If the treatment has any possible risks
• How well the treatment works

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 a research treatment on the particular disease or condition being evaluated.

Phase III clinical trials compare the new treatment with the standard arthritis treatment.

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.