There are multiple organizations aiming to close the gender gap in clinical research. Recently, Prometheus, a registry architect, partnered with the Women’s Health Research Institute (WHRI) at Northwestern University Feinberg School of Medicine to re-establish a clinical registry for women.
Through the registry, the WHRI will re-enroll women of all backgrounds who are interested in participating in clinical trials.
We spoke with Nicole Woitowich, associate director at the WHRI, about the registry and, how the clinical trial industry has underrepresented women in research and how that is changing.
“Women have been underrepresented in clinical research for many years, and only now are we approaching parity,” Woitowich told us.
In an effort to continue to provide representation of women in clinical research, Woitowich said the WHRI will be relaunching its Illinois Women’s Health Registry with Prometheus. The registry will use Prometheus’ research platform to keep up with the registry’s demands and make it mobile friendly.
“For many years women were excluded from clinical research, particularly women in their childbearing years. This resulted from tragedies related to drugs which caused birth defects in the offspring of pregnant women such as thalidomide and DES (diethylstilbestrol),” Woitowich said.
The US Food and Drug Administration (FDA) historically excluded women of childbearing age from clinical research for fear of further issues. That movement was not overturned until 1993, Woitowich explained, when the National Institute of Health’s Revitalization Act mandated that women and minorities must be included in clinical research funded by NIH.
Woitowich said, “Since the 1993 NIH Revitalization Act, there has been an increase in women’s participation in research, yet, it’s taken almost 25 years and we are just now approaching parity.”
‘Approaching parity’ in 2018
Woitowich stated that when females aren’t included in research, no matter the level, it is detrimental to women’s health.
“We have decade-long gaps where we could have been doing more to advance women’s health. We know that there are sex differences between men and women, and by not including females or analyzing data by sex, we are losing out on half the data,” Woitowich explained.
In recent years, the FDA has been working to include women in clinical research. As Woitowich explained, when drugs go to market language is included about whether the drug was tested in women, and if there were any sex-based effects that came up during those trials.
She said this snapshot is a “step in the right direction” as it provides “transparency and visibility of who these research studies are being tested on.”
However, there are still areas of research that have few women participating in trials, such as cardiovascular trials, which underrepresent women despite the fact that cardiovascular disease is the number one killer of women.
Will 2019 be any different?
Looking to the new year, Woitowich hopes 2019 will see women of all races and ethnicities, socio-economic background, geographic background included in the research, as each demographic has been known to influence our health differently.
“We know that while women are included in clinical research we’re still not analyzing data by sex and gender,” she added. “I think if we start to analyze data by sex, ethnicity, race, socio-economic, even geographic location, this may have a big impact on the results and in turn, the health outcomes for the individuals in these research studies.”