FDA Says Not Enough Women and Minorities Studied in Clinical Trials

The U.S. Food and Drug Administration (FDA) released data on Nov. 21 from six studies reflecting a two-month period in response to a requirement under the "FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data" to make transparent the percentage of female and minority participation in clinical trials for medications intended for all populations. Their conclusion is that there are not enough women and minorities in clinical trials.

"I am pleased by this action step by FDA," said Phyllis Greenberger, President and CEO of the Society for Women's Health Research (SWHR). "But the news is discouraging. The data validates the concern we have expressed to the FDA for 25 years."

When a more diverse population participates in clinical trials, we increase the potential to know more about the extent to which different subgroups -- males and females, young and old, people of various racial and ethnic backgrounds, and patients with differing comorbid diseases and conditions -- might respond to a medical product. And when subgroup data are analyzed, we have available more information about the product that can be communicated to the public. The result is greater assurance in the safety and effectiveness of the medical products used by a diverse population.

"We commend the FDA for the effort in collecting and releasing these data to the public and we believe it is an initial first step towards reducing the disparities and lack of information on sex and ethnic differences," said Greenberger. "But as is evident, the percentage of minority participation is dismal, and while there are women in all of the trials, the numbers are not statistically significant to reach any clinical relevance."

The SWHR believes now is the opportunity to change the way clinical trials in drugs and devices are conducted. Research has identified sex and genetic differences in gastrointestinal, cardiovascular and neurological systems, among others.

We need to understand how these differences may affect the metabolism, absorption and elimination of medications in subpopulations. It is time to dismiss the idea of "one size fits all," and populate trials with statistically-appropriate numbers and analyze by sex in order to achieve the right medication and correct dosage for all populations.

Federal policymakers and the research community need to ensure differences are studied and analyzed. The pharmaceutical industry, the National Institutes of Health, the FDA, academia, clinical research organizations and other key stakeholders will have the opportunity to focus on these disparities and identify the barriers and challenges in educating, recruiting and designing clinical trials.

"We will lead an effort to bring these stakeholders together to make meaningful changes in the involvement of women and minorities in clinical trials to better inform the diagnosis, treatment and prevention of diseases and conditions," said Greenberger.

The Society for Women's Health Research (SWHR�), the national thought leader in the study of sex differences in disease, is dedicated to transforming women's health through science, advocacy and education. SWHR advocates for increased public and private funding for women's health; greater inclusion of women and minorities in medical studies; and analysis of the biological differences between men and women in disease and health issues.

For the latest information and history of sex and gender research, visit SWHR.org.