CLINICAL RESEARCH TRIALS

Medical diseases include a variety of conditions constantly undergoing research to develop safer medical treatments and cures. As a person with one of these conditions, you or someone you know may be taking one or more medications to treat the symptoms. Before the medications are approved, they have to undergo strict testing to be sure they are safe and effective. This process of testing a study medication or other treatment is called a clinical trial.

WHAT IS A CLINICAL TRIAL?

A clinical trial is a research study performed by physicians and other health professionals to help determine if a medication is safe and effective. A clinical trial may be funded by an investigator (physician) or drug company. The Food and Drug Administration (FDA) requires that clinical trials be done before a particular drug is approved for use by the general public.

WHAT INFORMATION WILL BE PROVIDED?

Before patients agree to participate, they receive detailed information about all parts of the clinical trial. Participants are asked to read and sign a paper called a consent form. This form contains information about possible benefits and risks of the study medication or other treatment, planned procedures participants must undergo, and a list of other available treatments.

IS PARTICIPATION VOLUNTARY?

Participation is voluntary. Patients who decide to participate can choose to stop the clinical trial at any time or for any reason.

WHAT ARE THE BENEFITS, DISADVANTAGES AND RISKS OF PARTICIPATING IN A CLINICAL TRIAL?

Participants may benefit by receiving the study medication or other treatment before it is available to the general public. Patients will also receive the study medication or other treatment, physical examinations and laboratory tests free of charge, and some trials may provide financial payment.

The disadvantage is that, prior to starting the new study medication or other treatment, some patients must stop taking their regular arthritis medicines which may, in turn, result in worsening of their symptoms. Some trials require that participants take a placebo, a substance that looks like the study medication or other treatment, but is inactive. Studies have shown that 10-50 % of patients taking placebo will exhibit a favorable response. The goal of the clinical trial is to show that the new study medication is superior to placebo.

The study medication or other treatment may cause side effects which vary from person to person. Because the study medication or other treatment being tested is new, it is possible that unknown side effects may occur. You should ask your physician what is known about the risks and possible side effects specific to the clinical trial and study medication or other treatment.