A clinical trial is a research study that helps to show if a drug, device, test, or other treatment works and is safe. Some clinical trials use healthy people. Other trials use people who have a specific health problem that the research is studying. Read this page to help you talk to your healthcare provider about whether a clinical trial is right for you.
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.
More women are included in clinical trials than in the past. However, women still need to participate. It is important for women from different races and enthnic backgrounds to join a trial. Women of all ages and women with disabilities should also join. Your participation may benefit other women by helping doctor’s learn more about women’s health.
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
what happens when the study ends
Possible Risks and Benefits
the benefits and the risks/ side effects of the treatments
any other treatments you could get
if you can take your other medicines
You may not get any direct benefit from being in a clinical trial. The medicine or treatment may not work for you.
the costs you may have to pay
what will your insurance cover
if the study offers child care or transportation
who you should contact if you have questions or problems
how you will get the results
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.
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
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.
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.
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.
Starting in January 2016, you can join the Diverse Women in Clinical Trials Awareness Campaign. You can send out messages on social media. You can also help to educate the women in your community by handing out our free fact sheets. Stay tuned for an easy-to-use toolkit of resources for your outreach.
Learn More about Clinical Trials
- FDA Patient Network: Get basic facts and find FDA resources
Brochure: Become a Research Volunteer (Printer-Friendly)(PDF - 326KB)
- National Institutes of Health: Find clinical trials and other tips
- Video - Personal Stories from Women who Participated in a Clinical Trial
- Video - Breast Cancer Awareness: Clinical Trials