It all started with Thalidomide. Introduced to the market as an anti-nausea medication in 1957, Thalidomide was considered a safe solution for pregnant women dealing with morning sickness.
It wasn’t.
Thalidomide became a leading cause of birth defects in 1961. The scandal reshaped research. In 1977, women of childbearing age were barred from participating in clinical trials. And while the ban was reversed sixteen years later in 1993, experts still are trying to rebuild trust in clinical trials for women.
Last week in Edison, at HERHealth 2026, an annual event by the Healthcare Institute of New Jersey, panelists discussed the historical barriers that kept women out of clinical research and what the industry can do to provide access to trials that could benefit all.
The first obstacle: Many patients never hear about trials at all.
Sophia Hurtado, Associate Vice President & Head of Global Clinical Operations at Organon & Co. cited data recorded over the past five years showing that 64% of adults with chronic conditions were never told a clinical trial was an option.
“I do think we’re putting too much pressure and expectations around women to find trials and to be aware and to do their own homework,” she said.
She went on to say that clinical trials are focused on the needs of the trial rather than what patients are looking for.
Shemika Austin, Novo Nordisk’s Clinical Research Equity Sr. Manager, agreed.
“No one should have to google ‘I just got diagnosed with a cardiovascular disease. Let me go find a clinical trial,’” she said. “Put it as part of routine care. Go where the patients are, go where the women physicians are, and the insights will look a little bit different.”
But participation barriers don’t end with education. Transportation, childcare, work … basic day-to-day challenges can keep a patient from potentially lifesaving care.
To get women in the trials, researchers will need to accommodate them, the panelists said.
Cooper Medical School’s Jocelyn Mitchell-White offered some examples.
“Have the ability to cover the costs of childcare, of transportation for these patients,” she said. Have things that are done on weekends when people aren’t working or in evening hours.”
With a newfound growing awareness, trials are beginning to better educate and accommodate women participants. Austin described a recent cardiovascular trial she worked on that enrolled a much higher rate of women than average.
“Typically, cardiovascular trials recruit 8% women,” she said. “We recruited 42% because we helped them get there. We added, we paid sites to stay a little extra. All of those things, that’s when women came in.”
