2016

WOMEN IN CLINICAL TRIALS

= HOPE

Clinical trials are research studies that help to 

show whether a test or treatment works and 

is safe. There are many ways you can take 

part in a trial. Some trials ask you questions 

about treatments you already take. In other 

trials, you take a new drug. Some clinical 

trials use healthy people. Others use people 

who have a specific health problem.

Are Women in Clinical Trials?

Yes. Women are already in clinical trials. However, women from diverse backgrounds 

still need to participate. Women of all ages, racial and ethnic groups, and women with 

disabilities or chronic health conditions should think about being in a clinical trial.

You can help by considering a trial for yourself. You can make a difference by 

helping doctors learn more about women’s health. 

Why Should Women Participate?

Medical products can affect men and women differently. It is important that women 

participate because women sometimes have different side effects. A woman’s body 

can also affect how drugs and devices work.

Ask your healthcare 

provider if a clinical 

trial is right for you. 

FDA Office of Women’s Health

www.fda.gov/womeninclinicaltrials
15 Things You Should Know 

Before You Join a Clinical Trial

Being in a clinical trial is your choice. You should not feel pressured to join. 

You have the right to quit at any time. There are rules to protect people in clinical trials.

Informed consent is the process of learning the key facts about the clinical trial before 

you join. This list is not everything you need to know, but it will help you start the 

conversation. Make sure that you have your questions answered before you agree to 

participate. Find out:

The Purpose and What Will Happen

1. The purpose of the study

2. The drugs, tests, and treatments 

you may receive

3. How long the study will last and how 

many times you will have to come

4. How they will keep your 

information private

5. What happens when the study ends

The Possible Risks and Benefits

The trial may provide treatments or screenings, 

but there is no promise that your health will get 

better. The medicine, test, or treatment may not 

work for you.

6. The benefits of the treatments 

7. The risks and side effects of 

the treatments

8. Any treatments or other options for 

people with your disease

9. If you can take your other medicines

Any Other Support or Possible Costs

10.What treatment or services the 

study will pay for 

11. If the study offers child care 

or transportation

12. The costs you may have to pay

13. What your insurance will cover

How to Get More Information

14. Who you should contact if you 

have questions or problems

15. How you will get the results

What is FDA’s Role?

The U.S. Food and Drug Administration (FDA) makes sure medical treatments are safe 

and effective for people to use. FDA does not develop new treatments or conduct 

clinical trials. 

The FDA Office of Women’s Health is partnering with the NIH Office of Research on 

Women’s Health on an initiative to promote the participation of diverse women in clinical 

trials. To learn more about these activities, go to: 

www.fda.gov/womeninclinicaltrials