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  1. Diverse Women in Clinical Trials

Women in Clinical Trials: For Patients

From the FDA Office of Women's Health

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Diverse Women_OWH

On this page: Frequently asked questions | Pregnant and breastfeeding women | Search for a clinical trial | FDA’s role | Resources | Related links 

Frequently asked questions about women in clinical trials

What are clinical trials?

Clinical trials are a type of research study that test investigational medical products in human volunteers to see whether these products should be approved or cleared for wider use in the general population. A medical product could be a drug, medical device, or biological product, such as a vaccine, blood product, or gene therapy. 

Clinical trials help bring new medical products to people who need them. There are many ways you can volunteer to take part in a trial. Some clinical trials enroll healthy people. Other trials enroll people who have a certain health problem. Read this page to help you talk with your health care provider about whether a clinical trial is right for you and how to find clinical trials near you.

Are women in clinical trials?

Historically, women have not always been included in clinical trials. Over the years, efforts have been made to promote inclusion of women of all ages, women from all racial and ethnic groups, women with disabilities or chronic health conditions, as well as those who are pregnant, lactating or breastfeeding in clinical trials. Women who participate in clinical trials can help improve the health of all women.

Why should women participate in clinical trials?

There are important differences between men and women that can affect health, disease, and response to treatment. FDA looks for those differences. It is important that diverse women volunteer to participate in trials to help improve the generalizability of trial results across the population of patients who may use the medical product. By volunteering to join a trial, you can make a difference by helping health care providers and scientists learn more about how medical products affect women, and if the medical products are safe and work well in both men and women.

What is informed consent?

Informed consent is a process that involves providing a potential trial participant with enough information to make an informed decision about participating in the clinical trial. Informed consent includes helping potential participants understand what will happen during the trial if they agree to participate and provides them an opportunity to ask questions and consider whether to participate. The informed consent process involves providing additional information as the clinical trial progresses or as the participant or situation requires. It also includes the participant’s voluntary agreement to participate. To be effective, the process of informed consent must provide sufficient opportunity for the participant to ask questions and to consider whether to volunteer to participate.  

What are some things to know before volunteering to join a clinical trial (clinical study)?

This is a list of questions that you can consider asking before you volunteer to join a clinical trial (study). It is not everything you need to know, but it can help you start the conversation. Make sure any questions you have about participating have been answered before you volunteer to join a trial. 

Find out:

The purpose of the trial and what will happen during the trial

1. Why is this trial being done and how long will my participation in the trial last?

2. What procedures (steps) will be followed?
    a. Are any products used in the trial experimental? If so, can you tell me about them?

3. What drugs, tests, or other medical products will I or might I receive?

4. Can I take my current medicines?

5. How often will I need to follow-up with the trial team at the clinic (or check-in virtually)?

6. What will happen when the trial ends?
    a. Will I still have access to the medical product being studied when the trial ends?
    b. Will the researchers continue to check on my health?

7. Will I get the results of the tests that are conducted on me during the trial and the results of the trial once it is done?

The possible benefits and foreseeable risks

A trial may provide investigational medical products, but there is no promise that your health will be better. The medical product being studied may not work for you, but the trial may help other people.

8. What are the risks (side effects) of participating in the clinical trial?
    a. What risks are more likely to occur and what are the serious risks?  
    b. Will I likely feel discomfort or pain?

9. What are the potential benefits of the medical product being studied?
    a. What are the potential benefits to me?
    b. What are the potential benefits to others, such as future patients with my disease or medical condition?

Other treatments or procedures

10. What different treatments or options are available for people with my medical condition?
    a. Can you tell me about other appropriate options, like medicines or surgery that might help me?
    b. Can you describe the care I would likely receive if I chose not to join the trial?

Confidentiality or privacy

11. Will my trial records be kept confidential or private?
    a. How will my personal information be protected? 
    b. Will my personal information be shared with anyone?

Financial and other support

12. Will I be paid to participate in the clinical trial?

13. Will I receive reimbursement for expenses I might incur as a result of participating in the trial and, if so, what will be reimbursed?

14. What products or services will the trial provide or pay for?
    a. What costs, if any, could I have to pay for?

15. What products or financial support may I be given if injury occurs?
    a. Where may I get more information?

How to get more information

16. Whom should I contact if I have questions or problems?
    a. If contact information changes during the trial, how will I get the new information?

How pregnant women can participate in research

Many women may need to get a vaccine or take medication while they are pregnant or breastfeeding. They may need treatment for a health problem they had before becoming pregnant or one that started or got worse while pregnant or breastfeeding.

Sometimes, women who are pregnant may volunteer to join clinical trials for investigational medical products, including investigational vaccines. But, more often, pregnant women volunteer to join a pregnancy exposure registry. 

Pregnancy exposure registries are studies that collect information about how medicines taken, or vaccines received during pregnancy, affect those who are pregnant and the developing fetus. Some registries also collect information about the infant for a period of time after birth. The information collected can help health care providers and others who are pregnant learn more about the safety of medicines and vaccines used during pregnancy.

For more information, see: Pregnancy Exposure Registries. Breastfeeding women can also volunteer to join a study, such as a lactation registry. Talk with your health care provider for more information. 

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 area. You can search for a clinical trial for a specific disease or health condition. 

Search for a clinical trial 

FDA’s role

FDA works to make sure that there is reasonable assurance of the safety and effectiveness of medical products intended for human use. FDA oversees clinical trials of medical products we regulate to help ensure they are designed, conducted, analyzed, and reported according to FDA requirements. Diversity in clinical trials can help to ensure that medical products are safe and effective for everyone who uses them.

FDA Drug Trials Snapshots provide consumers and health care professionals with easy-to-read information about who participated in clinical trials that supported the FDA approval of new drugs.

Resources

Related links

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