Historically, women have been underrepresented in clinical trials, however, that paradigm is changing. This shift is mainly due to policy changes in the last three decades, but today many innovators are also seeing a role for tech to play in closing this gap.
This morning MobiHealthNews sat down with a panel at Women of Wearables’ FemTech Forum to moderate a discussion about the gender gap in clinical research, which focused on people who menstruate and experience menopause.
“In general the health authorities these days, at least from pharma companies, request data that reflects the user population, and obviously for most areas like cardiology or oncology, [that] means that you have to enroll women in the clinical trial,” Dr. Ilka Schellschmidt, head of women’s health clinical development at Bayer and a trained OB/GYN, said during the panel.
It’s been a long road towards representation. It wasn’t until 1994 that the U.S. National Institutes of Health mandated that women be included in clinical trials. Before this, there had even been a policy passed in 1977 limiting the ability of women of childbearing age to participate in phase one and phase two clinical trials, due to potential birth defects.
Schellschmidt noted that, while pharma has made progress, it is harder to regulate academia, and using male subjects takes away the risk of fetal defects.
“So sometimes people take the safe approach and test men,” she said. “In general I would say that if you look at the big trials that have been published in various areas in oncology, you see a fairly representative participation of women these days.”
Strides have been made in clinical trial representation over the years, yet tech may be a new avenue for facilitating further inclusion.
“So when you think about how research and data around women’s health is changing, technology gives you so many more options compared to a typical small clinical group or a clinical focus group to collect and learn a lot about women,” Jill Angelo, founder of menopause-focused startup Gennev said this morning. “One thing we’ve learned about women in menopause is we don’t know much about them. There hasn’t been a lot of research on them, nor have we looked at the hormonal changes that are happening in their bodies related to their risk of cardiovascular disease, or dementia, or Alzheimer's, or bone health.”
Diversity in clinical trials
Clinical trials that do include women don’t always look at diversity of age, ethnicity or socioeconomic income.
“A big issue is this gender data gap. The research has been nearly nonexistent, but when it has happened, often it has been on like a pool of 30 women in the U.S. [who are] white, 24-years-old,” Helene Guillaume, CEO of Wild.AI, said during the panel. “So there is also not a diversity in terms of age, life stage, ethnicity – which is an issue because ... for women our bodies are ever changing through these big life changes and when we are menstruating.”
Panelists said that tech could be used to help reach a broader scope of women; however, globally, access to digital tools like smartphones isn’t a given.
“If you look at developed countries, there is no good excuse not to be serving different ethnicities. So I think that is definitely a role,” Guillaume said. “For instance, if you look at the U.S. population, we can definitely address all the different ethnicities, but if we look at the world, we do need to have women who have access to a digital tool. I think there is still possibly a gap.”
While there is increasingly a focus on including more females, the panelist also discussed the importance of including people of color in research. Angelo said that this effort has to be deliberate. She recently collected responses from 50,000 users on her app, and noticed a similar representation issue.
“Less than 15% of all those respondents are women of color, or African American women, or Black women,” Angelo said. “So we see the huge deficit in our numbers being representative of a diverse set of women. I think what that comes back to in terms of our responsibility as a healthcare provider is we need to be targeting those women. We need to go where they are.”
Giving diverse groups of individuals a place at the table – whether that be in research, venture or startups – could help change this paradigm.
“I appreciate the role of tech, and generating really excellent data sets that help inform health choices for women now,” Schellschmidt said. “I think fundamentally we are still of the opinion we can do whatever we want, but until we really change the gender representation in science and in senior science positions, ... if these people don’t show up in senior positions, we won’t be able to change the situation to the degree that it is necessary. If cardiologists are male and white, they will study male white patients. That’s somehow still, I think, an issue. We are trying to circumvent that situation, but I think the underlying society problem we have here we need to address as well.”
Having more women in leadership could also make it easier for female-led startups to get their break.
“I think that the more women we get in capital decision-making positions, we actually will not have to fight so hard for female founders to get funded, or femtech to get funded, because the women general partners of funds will see the problem, and you only have to have one slide,” Brittany Barreto, CEO of Femtech Focus, said on the panel. “Similar to cancer – you know biotech companies have one slide that says cancer is bad, and the rest of the slides in their pitch deck are about their solution. Jill won’t have to have 5 or ten slides talking about what is the science of menopause when the room has experienced it.”
Are trials safer for women now than in the 70s?
There are still risks associated with women of childbearing age participating in trials, but tech startups are looking for ways to mitigate that risk.
“The startup I’m working with here in Houston is looking at specific cells that have to do with embryo attachment to the cell walls of the uterus and development, and so apparently… to this day we don’t know if drugs cause birth defects until [babies] have birth defects and then they retroactively label it as such,” Barreto said. “So they are trying to create this assay they are trying to sell to pharmaceutical companies so that they can run it at least once before it gets out of the lab, so that women can be included in clinical trials.”
Because of the risks associated in trials, historically drugs have been able to go on the market without specific testing of pregnant women.
“One thing I find shocking is, because we think there might be a risk, we prefer to be completely blind. So we are like 'OK, maybe she is going to be pregnant, so let’s not test women at all,'” Guillaume said.
Pharma and digital health partnerships
When it comes to the world of research, it’s no secret that pharma has the purse strings. Today we are seeing more and more pharma companies tap digital health startups. This is true in women’s health as well.
“In women’s health we have a beautiful situation where we can basically offer more or less lifelong support for women,” Schellschmidt said. “We start with puberty, with first contraceptive needs, then family planning, up and until menopause, and obviously we can cover related diseases. … That is something where women have a lifelong journey with their body. That is where tech and pharma, with their drugs that we try to develop, could really form a wonderful platform to help women manage that life journey together.”
While both entities have something to bring to the table, it is also important to address privacy agreements with patients.
“I think finding the right partnership between digital health companies and pharma is the absolute right thing to do, because, if we have the means to collect the data at scale and support the pharma institution that is equipped and financed to do the clinical trials and drug innovation, that’s the utopian model,” Angelo said. “I think on the data side – and one thing we struggle with is how do we ensure that our users or the individuals providing the data to us, we are respecting that data and are getting the right permissions for innovations down the road and [are] not in the position of selling the data. There you have to be incredibly transparent.”
Pharma and digital health companies may have a different way of tackling problems, but Schellschmidt said that working together could make for a more innovative future.
“We try to be open for dialog and coaching, even if the idea is not of primarily commercial interest,” Schellschmidt said. “We are available to coach and talk to the startups and give them feedback, and tell them our view. ... Maybe that even evolves into a different idea, into a different vision. I think it can be quite helpful to find someone who can try to offer that.