Dr. M.J. Bazos,
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
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.
INFORMATION WILL BE
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
voluntary. Patients who decide to participate can choose to stop the clinical
trial at any time or for any
WHAT ARE THE
BENEFITS, DISADVANTAGES AND RISKS OF PARTICIPATING IN A CLINICAL
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.