Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials

Women in
Clinical Trials
A clinical trial is a research study
that tests how medical treatments
work. Clinical trials help to show if
medical products, tests, and other
treatments are safe and effective.
Clinical trials are done with people
not animals. Some clinical trials
use healthy people to test new
treatments. Other trials use people
who have a specific health problem
that the research is studying.
Whether you are a healthy or
patient volunteer, you may not get
any direct benefit from being in the
clinical trial. The treatments may
not work for you.

What should I know before I
participate?
Talk to the researcher to get the
facts about the clinical trial before
you join. Find out:
The Purpose and What Will Happen
• the purpose of the study
• the drugs, tests, and treatments
you will receive
• how long the study will last and
how many times you will have to
come
• how they will keep your
information private

Use this fact sheet to help you talk
to your healthcare provider about
whether a clinical trial is right for
you.

Possible Risks and Benefits

Why should women participate?

• the benefits and the risks/ side
effects of the treatments

• what happens when the study
ends

Medical products can affect men
• any other treatments you could
and women differently. Sometimes
get
women have different side effects. It
is important that women participate • if you can take your other
medicines
to show if products are safe and
work well in both men and women.
Costs
More women are included in clinical • the costs you may have to pay
trials than in the past. However,
• what will your insurance cover
women still need to participate.
Your participation may benefit
• if the study offers child care or
other women by helping doctor’s
transportation
learn more about women’s health.

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Women in
Clinical Trials (continued)

Contact Person
• who you should contact if you
have questions or problems
• how you will get the results
What is informed consent?
Informed consent is the process
of learning the key facts about the
clinical trial before you join. Make
sure that you have your questions
answered before you agree to
participate.
Being in a clinical trial is your
choice. You should not feel
pressured to join. You have the right
to quit at any time.
What is FDA’s role?
FDA does not run clinical trials.
FDA, other government agencies,
and review boards set rules to
protect people who participate in
clinical trials. FDA also inspects
some clinical trials for products
regulated by FDA.

How does FDA use clinical trials
data?
FDA uses the information from
clinical trials and other sources
to decide if a product is safe
and effective. FDA reviews the
information for certain kinds of new
products before they are approved
to be sold to the public. Not all
products are tested in clinical trials.
How can I learn more about clinical
trials?
• FDA has a website to help patients
and their doctors learn about
clinical trials, drug safety, and
much more. Visit the FDA patient
network at:
www.patientnetwork.fda.gov
• The National Institutes of Health
(NIH) also has a website where
you can search for clinical
trials and learn more about
participating in clinical research.
Visit the website at:
www.nih.gov/health/clinicaltrials/
index.htm

To get other women’s health materials, go to:
www.fda.gov/womens

TAKE TIME TO CARE... For yourself, for those who need you.