Partnership aims to advance women's health research

Three decades ago, the National Institutes of Health set out guidelines requiring women and members of minority groups to be included in federally-funded research.

Lori Frank, president of Women's Health Access Matters, and Ash Shehata, KPMG U.S. sector leader for healthcare.

More than 30 years after the passage of the NIH Revitalization Act, there’s still much work to be done. KPMG and Women’s Health Access Management (WHAM) are working together to move the needle.

They have formed a new, $1.1 million partnership to accelerate women’s health research. The organizations have set out a number of goals, including publishing a report on investments in women’s health, creating an “investment index” of case studies, and analyzing data to gauge the effectiveness of treatments for women.

“There's a huge amount of business value in this space that unfortunately, as a society, and as an economy, we haven't fully even begun to understand,” says Ash Shehata, KPMG U.S. sector leader for healthcare.

Even though women make up more than half the U.S. population, women’s health has yet to gain adequate funding and research attention, says Lori Frank, the president of WHAM. Last year, WHAM teamed with the RAND Corporation on a report that illustrated shortcomings in funding for women’s health, noting that only 4.5% of coronary artery research and 12% of Alzheimer’s research projects are focused on women.

Many people simply aren’t aware of the lack of funding and attention on women’s health, Frank says.

“When we share with people what the disparities really are, especially around the data, the evidence base around women, people are incredulous,” Frank says.

(See part of a conversation with Lori Frank and Ash Shehata in this video. The story continues below.)

Increasing funding

WHAM is a fairly new nonprofit organization. Carolee Lee, who built a hugely successful fashion and accessory company, founded WHAM in 2020 with designs on making a difference in women’s health. She was recently named to the inaugural Time 100 Health list.

In 2023, noting the 30th anniversary of the NIH policy to require women in medical studies, WHAM launched the “#3not30” campaign to double funding for women’s health research in three years.

President Biden’s administration has boosted funding for women’s health. The White House has committed $100 million for women’s health research. “Women are more than half of our population but research on women’s health has always been underfunded,” Biden said in the State of the Union address in February.

The Advanced Research Projects Agency for Health, also known as ARPA-H, is leading the effort. The new federal agency is charged with pursuing innovative studies.

“The community has been thrilled to see the ARPA-H involvement,” Frank says, adding, “ARPA-H is all about accelerating solutions. So that's part of why we were so excited to see it.”

• Read more: Women’s health is starting to get more funding, finally

WHAM has focused on both economics and equity. The organization says adding $350 million in funding for women’s health would generate nearly $14 billion in economic returns.

“The economic arguments, the business case, should help to raise awareness and make that connection for people who might not have been thinking about this very disparity,” Frank says.

The increased federal funding is going to spur more work from healthcare organizations, and attention from investors.

“I think it's going to really kind of electrify the investment community behind this as well,” Shehata says. “So it's a great start. We know that there's a lot more that needs to be there.”

Expanding access to trials

Healthcare leaders say more women should be participating in clinical trials, and the lack of women can undercut studies of the effectiveness of new therapies.

Women make up only about a third (38%) of the participants in clinical trials for cardiovascular disease, according to the American Heart Association.

Part of the reason for the underrepresentation of women in clinical trials is tied to a lack of understanding. Researchers have been slow to recognize that women aren’t just smaller men. Women have their own unique physiology and respond to diseases, and medications, differently, Frank and other advocates say.

“Clinicians and researchers are trained in a certain way, with a certain received body of knowledge,” Frank says. “And it has largely rested on the premise that the difference clinically between men and women is negligible and didn't need to be accounted for. But the more we learn, the more we know that in fact, there are meaningful differences clinically.”

Women face other obstacles in participating in medical research. Many women, even if they work outside the home, end up taking the lead in raising children and, increasingly, caring for aging parents.

“Women often have primary informal caregiver responsibility within a family,” Frank says. “So that is definitely one of the barriers.”

WHAM is advocating for more “decentralized models” of clinical trials, to take studies to where people in the community live, as opposed to requiring them to travel to academic medical centers.

“We see that as a good way to overcome one of the barriers,” Frank says. “But also, it's as simple as asking people. So a number of people, especially from communities that have been underrepresented in clinical studies, just aren't often asked to participate in research. And so that's why expanding access to trials is one of our goals.”

Data is ‘a cornerstone’

In partnering with WHAM, KPMG will bring its capabilities in data analysis and project management. Shehata says the collaboration with WHAM “was really formed on the premise of data.”

“I think this data piece is a cornerstone,” he says.

As WHAM and KPMG gain greater insights and data on women’s health, Shehata says stakeholders can look at areas where there can be measurable progress, and it’ll be possible to monitor and measure investment strategies, he says.

“I think it's going to start to engage providers and payers and community advocates and government in a way that, once you look at this data, you can't, ‘un-think it’ now, because it's in everybody's common vernacular,” Shehata says. “And I think that is going to be a very pivotal part of this discussion. So, you know, we are really excited about data. And I think data is going to be an underpinning to it. And it's going to be an underpinning to how organizations think about the investments they’re making.”

Shehata also sees the potential of artificial intelligence to help advance studies of women’s health.

“Clearly AI, I think, is going to be a big part of our ability to also further enhance the ability to extract and really target the communities that we need to represent the most, and I think also find ways to accelerate data access and accelerate clinical trials,” he says.

Evaluating success

KPMG expects to help spur investments in women’s health. Shehata sees a budding investment market in women’s health, and the increased data should spur more companies to enter the space and create “social-based investing.”

With assistance from the KPMG U.S. Foundation, Shehata also expects to see more charitable giving as well. But he also expects to see more for-profit companies getting involved.

“Once they start to see the advances, and they see the business case in action, it really is going to be a multiplier for us,” Shehata says.

Frank says an important measure of success will be the growing recognition of the need to invest more in women’s health research, “where people are no longer unaware and surprised when they hear the data.”

When asked how she will define success, Frank says she hopes “people understand that sex and gender are variables that are truly important to any research, and build them in, and it's just a matter of course. And then the evidence base about women's health expands, along with the evidence base on human health, generally.”

“Ultimately, success is meeting what is now a large unmet need,” Frank says.