Researcher identifies underrepresentation of women in oncology studies
Healio’s Women in Oncology series has addressed a multitude of gender equity issues in medicine among health care professionals, but Kristina Jenei, BSN, MSc, has also found that underrepresentation of women is present among trials.
Jenei, a research coordinator at the School of Public Health, University of British Columbia, spoke with Healio about her research published in JAMA Oncology on the inclusion of women in global oncology drug trials over the past 20 years. Only 40% of the participants of 505 oncology clinical trials that she and colleagues evaluated were women.
!["If we don’t have enough women [in a study], the results for how well a drug works is uncertain. We should be at least enrolling women in proportion to the disease burden in that population." - Quote from Kristina Jenei, BSN, MSc](/~/media/slack-news/hemonc/content-bundles/resource-centers/women-in-oncology/2021/hot_wio0921jenei_graphic_01.jpg?w=800)
Jenei said that the concept for the research came from her time working as a pharmaceutical officer at the Canadian Agency for Drugs and Technology in Health. During her time with the agency, she noticed that women seemed underrepresented in studies and a systematic search could potentially shine a light on this discrepancy.
Healio: What is the importance of equal inclusion of women in these trials?
Jenei: It basically comes down to how we extrapolate the results from these studies. Clinical studies, such as trials in oncology, investigate the effect of a drug or other treatment. We use these studies to make clinical guidelines, approve medicines and prescribe in practice. But, to truly understand how well a drug works in a subset of the population, we need to have enough participants in the study. If we don’t have enough women, the results for how well a drug works is uncertain. We should be at least enrolling women in proportion to the disease burden in that population.
We also need to acknowledge physiological differences between men and women. Studies have found that these differences (eg, hormones, weight, gastric motility, etc) influence the activity of a medication. Ironically, these female differences were historically used as an excuse to exclude women from clinical studies. Decades of important feminist advocacy paved the way for regulatory mandates that stipulate women be included in trials (eg, NIH Revitalization Act).
As our understanding has evolved, we know these physiological differences actually make it critical to study the medication with women.
Healio: Have you found other reasons for this discrepancy in current studies?
Jenei: There’s a multitude of factors that can influence participation in clinical trials. For women, it might be partly due to historical exclusion in medicine and behavioral factors. Lately, I’ve been reading about how women have not only been excluded from trials but also not included in larger domains of medicine, such as academic leadership positions, program directors, principal investigators and authors in predominant oncology journals. I have also found research that showed behavioral characteristics among women that they will be less likely to enroll in a trial if it involves significant risk.
Healio: Regarding the marginal increase of women in trials from your research, do you think there is a way to significantly grow that rate?
Jenei: One of the things we looked at were different characteristics between men and women regarding trial phase, years of enrollment, tumor type and other factors. Interesting enough was funding. There were significant differences between the percentage of women in industry-funded trials vs. NIH studies. Women were more likely be enrolled at higher rates in NIH studies. That’s interesting because there are regulatory policies that encourage NIH-funded research to adequately include women in studies. It would be interesting to follow-up on this and study whether these regulatory initiatives have influenced trial enrollment. We’re getting close to equal numbers of men and women in NIH studies (48% women and 52% men) vs. the 40/60 split in industry.
But regulatory policies aimed at publicly funded research is only one side to the coin. Most studies these days are funded by industry where these mandates do not apply. Therefore, regulatory initiatives must include them, too. Here, I think the FDA has an opportunity to ensure studies that underpin approvals have adequate numbers of women to draw clinical conclusions.
I also wonder about journals, which I think play a part in this too. They might make it a requirement for publication that investigators report their outcomes by sex and that these analyses are methodologically rigorous (eg, enough participants are pre-planned, etc). Taken together, we might then actually begin to address a culture of medical inequity while creating incentives for an equal number of men and women in oncology studies.
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For more information:
Kristina Jenei, BSN, MSc, can be reached at kjenei@mail.ubc.ca and on Twitter at @kjmeetswrld.
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