Anyone intererested in participating in a clinical study should feel comfortable about the study and know as much as possible regarding participation in clinical research.

1. Clinical Trials – What You Need To Know
Clinical Trials – What You Need To Know

2. The following will provide you with
some information about participation in
clinical research.
Before a medication can be used, drug
companies conduct clinical trials to
ensure that it is safe and effective.

3. WHAT IS A CLINICAL TRIAL?
A clinical trial is a
research study in
human subjects under
the direct supervision
of experienced
physicians.

4. SAFETY IS FOREMOST
 These trials study new treatments
following strict rules set by the Food and
Drug Administration (FDA).
 A independent group from the community
called an IRB* helps protect study
participants by making sure the study is
compliant with the law.
* Independent Review Board

5. Every medication currently
available is the result of a
group of people who
participated in a clinical
trial.

6. WHY PARTICIPATE?
People join clinical trials for a variety of
reasons.
Many people with a chronic health
condition choose to join a clinical trial to
receive a study medication that could
potentially improve their symptoms.

7.  Other people want the satisfaction of
knowing they may ultimately help
someone with a chronic or serious illness
by advancing medical research today.

8.  Some people join a clinical trial to have
access to no-cost health assessments.
• All study-related clinic visits, physical
examinations and diagnostic tests are
provided to those who qualify at no charge.

9. A carefully conducted clinical trial is the
fastest and safest way to find treatments
that lead to new and improved medicines.

10. CAN ANYBODY PARTICIPATE?
 All clinical trials have guidelines. These
are based on things like age, gender,
previous medical treatments and other
conditions.
 Not everyone who wants to participate in a
clinical trial will be accepted.
 Some studies need healthy volunteers,
while others studies require patients with
the illness or condition being studied.

11. ARE THERE RISKS?
 The Informed Consent Form will clearly list the
known side-effects of the study medicine.
 Because the medications being tested are new,
some side effects may still be unknown.
 Known risks are fully explained by the clinical
trial staff.
 Medications being tested can have unpleasant
or serious side effects.

12. WILL MY PRIVACY BE PROTECTED?
 All medical records and research
materials that identify participants are kept
confidential as required by law.

13. If accepted into a clinical trial, you can stop
your participation in the trial at any time for
any reason.

14. FIND OUT MORE
If you think you are a good subject and have
an interest in clinical trials, there are a many
good websites with additional information,
including:
•CenterWatch.com
•ClinicalTrials.gov
•Ciscrp.org

15. FIND OUT MORE
• Visit our current enrolling studies.
• Read more about participation.
www.ComprehensiveCD.com