Bonnie Brescia, corporate planning officer of BBK Worldwide, a patient and patient recruitment solutions provider, will chair a workshop at the upcoming DIA Global Annual Meeting to discuss the role and experience of females in clinical trials and research.
According to Brescia, the workshop will be an ‘engage and exchange’ in which she will facilitate a discussion to explore the female perspective through four lenses: Females as clinical trial participants, caregivers, leaders in the biopharmaceutical industry – and the concept of sex as a biological variable in research.
Set up in a seminar fashion with tables of women being prompted to discuss among their fellow attendees and then with the session as a whole, the talk is aimed to prompt industry members to look at the basis of sex in a new light.
According to Brescia, progress is already being made regarding the industry taking women into greater consideration, but there’s still a way to go. “I think there’s progress being made on all fronts,” she told us.
“In terms of how we reach out and try to introduce the idea of clinical research and study participation to women through traditional recruitment outreach, making that commitment to bring proportionate representation is one that’s done and great progress is being made on that,” she said.
“However, if the inclusion and exclusion criteria designed in the protocol worked intentionally or has built in an unintentional basis to exclude women that would be the next thing we would have to address.”
The four lenses that will shape the discussion all take this into account; and while changes have been made, Brescia said the industry has not yet turned a corner.
Biological variability
Brescia told us that because cells have a determined sex through biological coding, it is a variable that should be considered when studying disease or the treatment of a disease. Including women and ensuring there is an equal percentage of women in studies is one thing, she added, but it is not enough to provide meaningful analysis unless sex differences are considered in regard to how patients respond to treatment.
“That’s been one of the shortcomings and a lot of times the industry only looks at that after drugs have been approved, and we’ve got hundreds of thousands of people on the medication and women are responding differently to the medication,” Brescia said.
She explained that the biological variable of sex can cause different side effects and varying levels of intensity. Additionally, metabolic drug excretion differences across the sexes can impact dosing levels.
Pregnancy in clinical trials
Females also have hormonal changes that have been previously believed to confound study results, Brescia noted.
“While it is true that there are hormonal changes in women that are different than the hormonal changes in men and they are more profound, they’re not going away, that’s just part of being a woman, it’s part of being a female of any species, that’s just how it goes,” she said.
“So, to exclude women based on the fact that hormonal changes can add some complexity into the study and then have men only be represented or significantly or disproportionately represented and feeling like you’re doing an okay thing by having that drug approved for use by women and men and not looking at dosing issues is just a compound mistake.”.
However, Brescia believes there is the opportunity for pregnant women in studies to provide a lot of information, as 90% of pregnant women are taking some form of prescription or over the counter drug during their pregnancy.
Still, there are aspects that need to be considered regarding risk, she said: “A de facto exclusion of pregnant women in clinical research doesn’t cut it anymore. Even some government regulations are monitoring what’s happening with the inclusion of women and pregnant women in research studies.”
Brescia added that post-approval studies to focus on pregnant women would also be beneficial.
Females as caregivers
While there is a push to increase female participation in clinical trials, the role of females within research extends beyond the clinic, as caregivers.
According to Brescia, females have stated that when acting as a caregiver to a clinical trial patient, they are often faced with other obligations to attend too, and sites are often not assumptive of this. When a site can accommodate reimbursement of childcare costs, for example, females tend to feel more supported.
Females also tend to be more communicative and have shown a greater interest in mobile applications and devices used in clinical trials. This interest in mobile health relates to female caregivers, and caregivers in general, having access to staff outside of study visits and the opportunity to have questions answered related to obligations in terms of the study.
Women-led clinical research
Females also are not equally represented in the leadership roles at the organizations involved in clinical research. Brescia explained that 48% of all medical degrees in the US and 55% of science-related PhDs are issued to women, so men and women are evenly matched education-wise in the industry. However, by the time you get to leadership, 24% are women and 76% are men, and at the board level 86% are men and 14% are women.
Brescia told us that while there are probably many ‘well-meaning decisions’ that lead to these marginalized trajectories, if there aren’t people in the room who can push for biological variable analysis of sex to be built into the study design, then the marginalization can be prolonged.
Each lens poses further questions and creates opportunities for discussion; however, Brescia is also interested in the question of what does the industry want to accomplish in terms of female representation in clinical studies?
