When I went to medical school, human health was presented as a body of knowledge that applied to everyone. With the exception of reproductive health, men and women were considered pretty much the same. But over the past few decades, thankfully, we’ve undergone a sea change in how we view human health. Yes, much of what we know about human health is applicable to all of us. But we’ve increasingly come to appreciate that gender, race, ethnicity, and other factors can play a role in health and disease. And that means that if clinical research is to address public health issues, we must include a cross-section of our entire population in the research.
I think about this as one step toward the more individualized approach to human health that is the trajectory of medical practice and the aim of the Precision Medicine Initiative. And, because April is National Minority Health Month, I’d like to tell you about some resources to help investigators recruit the most diverse populations for their clinical studies.
Evidence of health disparities
There are many examples of health disparities by race, ethnicity, and gender. For example, Hispanic women have the lowest rate of cardiovascular disease (CVD), about 136 deaths per 100,000, while non-Hispanic Black men have the highest, 357 per 100,000. Black women have a higher CVD mortality rate than the national average of 223 deaths per 100,000, and the highest CVD mortality rate among any group of women.i
We don’t know a lot about why health disparities occur among people of different races, ethnicities, or genders, although we are learning more all the time. Access to health care can play a role, as can our genes and sociocultural factors. There is even emerging evidence that unconscious bias may sometimes play a role.
We need more clinical research to unravel the complex knot of variables that lead to different health outcomes for different groups of people. To do that, we must include the diversity of our population in our studies. That is why NIH policy and federal law require that women and minorities be included in NIH-supported clinical research studies.
And yet, we still see gaps in research participation across gender, race, and ethnicity. We must do better.
Recruitment tools to help
To help clinical investigators recruit a diverse population of women participants, the ORWH has created the NIH Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research. The toolkit identifies the barriers to participation among women and among underrepresented groups of women. It suggests solutions and includes case studies for both researchers and research participants.
We also have a wealth of information at Clinical Trials and You. This NIH website provides information to potential participants, resources for trial sites, and information for health care providers.
The effort to include a more diverse group of women in clinical trials goes well beyond the NIH. ORWH is also working with the Office of Women’s Health within the Food and Drug Administration (FDA) on the Diverse Women in Clinical Trials Campaign. This initiative encourages women of different ages, races, ethnic backgrounds, and health conditions to participate in clinical trials. FDA notes that medical products are safer and more effective for everyone when clinical research includes diverse populations.
I’m the co-chair, along with NIH Director Dr. Francis Collins, of the NIH Working Group on Women in Biomedical Careers. The working group has taken steps to ensure that more women enter and remain in biomedical careers, including women of color. As our cohort of clinical researchers becomes more diverse, the diversity of our volunteers is likely to become more diverse, too.
The work of my office is to ensure that women, including women from underrepresented groups, are included in all phases of research. I hope you will take the time to look at some of our resources, to use them, and to provide your feedback.
For more information
Office of Research on Women’s Health. Inclusion of Women and Minorities in Clinical Research. Retrieved April 13, 2016 from http://orwh.od.nih.gov/research/inclusion/index.asp
i Mozzafarian, D., Benjamin, E.J., Go, A.S., Arnett, D.K., … & Turner, M.B., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. (2016). Heart Disease and Stroke Statistics—2016 Update: A Report from the American Heart Association. Circulation, 133. PMID: 26811276