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Women in Clinical Trials

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Silhouettes of Women of Different Sizes and Ethnicities standing under a header that says Women in Clinical Trials... Make a Difference

 

A clinical trial is a research study that helps 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. Other trials use people who have a specific health problem.  Read this page to help you talk to your healthcare provider about whether a clinical trial is right for you.

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. Sometimes women have different side effects. It is important that women participate to show if products are safe and work well in both men and women.


15 Things to Know Before I Join a Clinical Trial

This list is not everything you need to know, but it will help you start the conversation. Make sure you have your questions answered before you agree to join a trial. Find out:

The Purpose and What Will Happen

1. the purpose of the study

2. the drugs, tests, and treatments you will 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 Benefits and Risks

You may not get any direct benefit from being in a clinical trial. The medicine or treatment may not work for you.

6. the benefits of the treatments

7. the risks and side effects of the treatments

8. any other treatments or options for people with your disease

9. if you can take your other medicines

 

Any Other Support or Possible Costs

10. what treatments 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 will your insurance 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 informed consent?

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

How do I find a specific clinical trial?

You can go to clinicaltrials.gov to search for a clinical trial. You can search for clinical trials in your city. You can search for a clinical trial for a specific disease. 

Search for a Clinical Trial 

  

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.

Watch video about FDA's role in increasing diversity in clinical trialsdisclaimer icon.

How can I spread the word about the Diverse Women in Clinical Trials Campaign?

The FDA Office of Women's Health is partnering with the NIH Office of Research on Women's Health to raise awareness about diverse women of different ages, races, ethnic backgrounds, and health conditions participating in clinical trials. The Diverse Women in Clinical Trials Initiative  includes a consumer awareness campaign, as well as, resources and workshops for health professionals and researchers. 

Use the Partner Toolkit to inform the women in your network about clinical trials. The toolkit includes resources for 'everyday' women and health professionals including fact sheets, sample social media and email messages, and articles.

Diverse Women in Clinical Trials Campaign Partner Toolkit 

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Page Last Updated: 06/23/2016
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