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Arthritis Studies: A Guide for Patients

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.

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