Participate in a Clinical Trial: Make a Difference

January 27, 2016 • By Marsha B. Henderson, Assistant Commissioner for Women's Health, U.S. Food and Drug Administration

I have worked in the health field for over 30 years. When I tell people I work at the U.S. Food and Drug Administration (FDA), they often start asking me questions about their health. "What do you think I have?" "Where can I find information on my disease?" "I've been taking this medication. Is there something better?" It recently occurred to me that during my career, only one person has ever asked me about clinical trials. Clinical trials just don't come up in casual conversations. Well, I want to change that. I want to get women talking about why it is important for us to participate.

Clinical trials are research studies that attempt to show whether a drug, device, test, or other treatment is effective. There are many kinds of trials. Some clinical trials use healthy people. Others use people who have a specific health condition. Some trials ask you questions about a treatment you already take, and in other trials, you take a new drug. Some trials test ways to screen or diagnose illnesses, rather than treat them.

Deciding to participate in a clinical trial is a decision that you make after talking it over with your health care provider and your family. As with all medical decisions, you have to consider the risks and benefits of participating. The trial may provide treatments or screenings, but there is no guarantee that your health will improve. Whether you are healthy or sick, the medicine, test, or treatment may not work for you.

I know firsthand. When I was diagnosed with glaucoma, I found that the standard treatments didn't work for me. My next step was to have a laser treatment, and that didn't work either. I went from worrying to being really scared. Luckily for me, surgery was an option and it is controlling my condition. After the surgery, my doctor asked me if I wanted to take part in a clinical trial looking at long-term outcomes.

I decided to participate because it might help other people who may need the same surgery in the future. I also participated because I know that medical treatments can affect men and women differently. Women sometimes also have different side effects. Likewise, women of different races, ethnicities, and ages and those with various health conditions and disabilities may have different medical needs from other women. It is important that clinical trials include the different kinds of patients most likely to use the medical products to show whether they are safe and effective in both men and women. This is why the FDA Office of Women's Health is launching a new national initiative to help raise awareness about why women of all kinds should participate in clinical research.

After reading this, I hope that you will start talking to other women about clinical trials. You might find out that someone you know has already participated or that a friend has been thinking about it but didn't know how to enroll. Even if you are not eligible for a trial, spreading the word to other women will help all of us.

We have made great strides in clinical research in the past 20 years. Many women are already included in clinical trials. To continue this progress, we must all play a part. You can help by considering a trial for yourself. Ask your health care provider if a clinical trial is right for you. Your participation can make a difference for your health and for the health of women like you.

Visit Women in Clinical Trials to learn more about joining a clinical trial.