Women in Clinical Research

Female Patient Being Reassured By Doctor In Hospital Room
Dwan Fellows
April 3, 2024

The culture in clinical trials in recent years has been very inclusive of women but did you know that women have not always been included in clinical trials? It is still recent that women are included in clinical research.

I will provide a brief history overview with links below if you would like more information:

Out of an abundance of caution it was typically recommended that women, and particularly women of
childbearing potential, be excluded from clinical research trials1. In fact, in the 1970s women’s health needs were considered a low priority in both science and medicine. This cautious approach led to a lack of data in how drugs, treatments, and procedures affected women.

It was not until the 1990s that the largest clinical trial included approximately 150,000 women over the course of fifteen years2. This became known as the Women’s Health Initiative. Also, in 1993, Congress passed a law3 to ensure that women (and minorities) are included in clinical trials.

Why should women participate in clinical trials? Let me offer some thoughts for consideration 4 :

  1. There are significant differences between men and women. These differences may affect health, disease, and how a patient responds to a medication or treatment. It is important for women to participate so that we, researchers and providers, have a full range of data in how medications and treatments affect women.
  2. Women who participate in a clinical trial help to improve the health of all women. While in a clinical trial you may receive benefit but the data and information that is provided with your participation will help researchers and providers treat women more effectively and safely,
  3. When women participate in clinical trials, a legacy of helpful information is provided that will benefit women in the future.
  4. It is important for women to know about the function of their own bodies. Women of previous
    generations did not talk about the symptoms or health issues that they experienced. This leaves younger generations with little information and little support as they become more vocal about what they experience. It has been my pleasure over the years to educate women in the realm of women’s health and their bodies as they participated in clinical trials.

At Fellows Research, we are happy to answer all your questions long before you decide to participate in a trial and will continue to answer your questions throughout your participation.


1 https://www.fda.gov/science-research/womens-health-research/gender-studies-product-development-
historical-overview and https://www.fda.gov/science-research/womens-health-research/gender-studies-
product-development-historical-overview
2 https://www.nhlbi.nih.gov/science/womens-health-initiative-whi
3 The NIH Revitalization Act of 1993 (Public Law 103-43) titled Women and Minorities as Subject in Clinical Research. https://www.ncbi.nlm.nih.gov/books/NBK236531/?report=reader
4 https://www.fda.gov/consumers/diverse-women-clinical-trials/women-clinical-trials-patients

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