A clinical trial is a research study to answer specific questions about
vaccines or new therapies or new ways of using known treatments.
Clinical trials (also called medical research and research studies) are
used to determine whether new drugs or treatments are both safe and
Carefully conducted clinical trials are the fastest
and safest way to find treatments that work in people. Trials are in
four phases: Phase I tests a new drug or treatment in a small group;
Phase II expands the study to a larger group of people; Phase III
expands the study to an even larger group of people; and Phase IV takes
place after the drug or treatment has been licensed and marketed.
Questions relevant to the trial should always be addressed to
the trial doctor for the duration of your trial participation. Any
clinical trial participation is always voluntary. In most clinical
trials the treatment, office visits, and all tests are free. You may
also be given financial compensation for participating in some cases.
Your doctor or the study coordinator at your doctor's office should
share information regarding the compensation package with you during
your first visit.
Are Clinical Trials safe?
Clinical trials are conducted in a healthcare
setting (a hospital or clinic) and are typically monitored by a
trained healthcare professional. An Institutional Review Board
or IRB approves all clinical trials. This is a committee made up
of doctors, ethicists, and members of the general public and
administrators. This group is held responsible for agreeing that
a trial does not represent an unreasonable risk to patients who
Trials are also reviewed by the FDA. Your
doctor is responsible for your well being and is the best person
to decide whether or not you are eligible to participate in a
trial. Whenever you agree to enter a trial you are given the
name and telephone number of a contact in your local physician's
office who will answer yourquestions as well as a member of the
IRB whom you can contact if you have any doubts.
How will I Know
if I am Eligible for a Clinical Trial?
Each trial has certain requirements
for participation. Your doctor will take a medical
history from you and may request additional testing to
determine if you are eligible according to the criteria
for the study.