What is a clinical trial?
Clinical trials are
research studies in which people help doctors find ways to
improve health care. Each study tries to
find better ways to prevent, diagnose, or treat health problems.
purpose of a clinical trial is to find out whether a medicine or treatment
is safe and effective for treating a certain condition or
disease. Clinical trials compare the effectiveness of this medicine or
treatment against standard, accepted treatment or against a
placebo if there is no standard treatment.
Taking part in a clinical trial
is voluntary. No one can make you participate. If you choose not to take part, you will be offered the standard
treatment for your health problem. You can talk to your doctor if you have questions about clinical trials.
Why are they important?
are important because they compare new treatments with accepted treatments.
They allow researchers to find out if a new treatment works as well as or better than
accepted treatments. The new treatment might have fewer or less serious side effects.
The new treatment also might not work as well or might cause more
side effects than standard treatments.
Clinical trials help drug companies make medicines that are safer and
more effective with fewer side effects. Clinical trials also help these
companies decide whether it is worthwhile to seek approval from the U.S. Food
and Drug Administration (FDA) for a certain medicine. If a medicine doesn't
work as well as standard treatment, then the FDA isn't likely to approve
Clinical trials are also important in finding treatments if no
standard treatment exists.
Taking part in a clinical trial may
not benefit you directly. But in the future it may help other people who have the
How do clinical trials work?
Your doctor will help
you find out if you are eligible to take part in a clinical trial. The
company sponsoring the trial will have a very strict set of standards, or criteria, that all
participants must meet.
If you meet the criteria, you may be "randomized" to
get either the new medicine, a medicine that is considered standard therapy, or a
placebo. That means that a computer is used to randomly assign you to one of
the treatments. In many studies, neither you nor your doctor knows which treatment you are
getting. But not all clinical trials randomize people. And if you have a
serious disease, such as cancer, you will not be given only a placebo, unless no
effective treatment is known.
After you are accepted by the clinical trial and you give your
consent to take part:
- You will be given a structured program to follow.
will have a schedule of tests, doctor appointments, and treatments.
- You may
be asked to keep a diary of your experience during this time.
Doctors, nurses, social workers, and
other health professionals may be part of your treatment team.
Be sure to carefully follow instructions. If you don't
know what you are supposed to do next, call your doctor. Or call the person
responsible for your trial.
medicine or treatment must go through three phases before it is
approved for use by the U.S. Food and Drug Administration (FDA).