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How digital twins are making clinical trials more inclusive
For decades, women have been excluded from clinical research, but AI-powered digital twinning is helping make trials safer, more inclusive, and more representative of real patients.
For Karen Yeo, innovation is not just about technology, but how it is used to change things for the better.
Yeo (pictured top left) is senior vice president of client and regulatory strategy at Certara, a biosimulation company focused on “transforming drug development for good”, which since 2014, has supported 90 per cent of novel FDA drug approvals.
Yeo and her team are using AI to make scientific research more inclusive by creating digital twins, matching the characteristics of a real patient with their digital counterpart to predict optimal dosing.
Women, particularly pregnant women, have typically been excluded from clinical trials for decades.
In 1977, following the thalidomide crisis of the 1950s and 1960s, the US FDA introduced guidelines preventing women of childbearing age from participating in many studies to avoid possible risks to pregnancies.
This was eventually lifted by the FDA in 1993, and the same year, the National Institutes of Health issued its Revitalisation Act, which required the inclusion of women and minorities in federally funded clinical research.
But while these changes opened the door to more representative trials, pregnant women continued to be excluded due to safety and ethical concerns.
“[Researchers] fear that exposing expectant mothers and their babies to experimental medicines could cause harm, so the default has been to leave them out,” Yeo tells Femtech World.
While “well-intentioned”, policies which prevented them from participating in clinical trials have contributed to “major gaps” in our understanding of how treatments work in women, and slowed down access to potentially life-saving treatments, leaving them facing “more risk, not less”, says Yeo.
“The result is a healthcare system where women are underserved,” she adds. “And both mothers and infants miss out on advances that could have been better supported through careful, inclusive trial design.”
The evidence gap
Excluding women from trials has delayed access to lifesaving therapies, and without the right evidence, clinicians often prescribe medications off-label during pregnancy with little understanding of how those drugs behave in women’s bodies.
For years, drug dosing was determined largely from small studies in men, even though women may metabolise and respond to drugs differently, Yeo explains.
“This gap has contributed to higher rates of adverse drug reactions in women and less clarity about the effectiveness of medicines in conditions unique to them, such as pregnancy and postpartum care,” she says.
Yeo points to the example of the antimalarial drug primaquine.
Pregnant and lactating women have typically been excluded from primaquine studies, leaving physicians without the right guidance.
Using biosimulation, Yeo and her team took the findings from a small clinical study conducted in breastfeeding women and were able to predict infant and newborn drug exposures through breast milk.
“The results provided evidence of safe dosing of primaquine in mothers, showing how model-informed methods can begin to close those gaps,” she adds.
Digital twins
By creating virtual representations of women’s physiology, including during pregnancy, biosimulation can predict how a drug will behave in these populations without exposing patients to any unnecessary risk.
This allows regulators and clinicians to access insights early and encourages trial sponsors to include women more confidently.
“Models can estimate how a drug transfers through breast milk, giving trial designers a foundation for guidance before patients are enrolled,” Yeo explains.
“This reduces ethical concerns by minimising direct risk while still advancing inclusive research.
“Over time, it shifts the approach from protecting women from research to protecting them through research.”
These digital twins start as virtual populations, representing typical physiological scenarios. But as more personalised clinical data become available in pregnant women, these can be replaced by digital twins.
These are digital replicas of individual patients reflecting real-time individual physiology.
Yeo says these AI-powered digital twins can provide a safe way to generate evidence in individuals that are difficult to study directly, such as pregnant women with preeclampsia.
While no model has yet perfectly captured human biology, Yeo says biosimulation has advanced to a point where it can reflect many of the complexities of women’s health.
“Virtual populations can account for physiological changes during pregnancy, such as altered metabolism, which can affect the exposure of the drug across each of the trimesters,” she says.
“Rather than oversimplifying, they provide a framework that can help inform decision-making for clinicians.
“As real-world and clinical trial results with personalised data become increasingly available, virtual populations can evolve into more complex digital twins.”
“Safeguards start with data”
But as with any AI-driven technology, poorly designed models or those that rely on narrow datasets risk reinforcing existing biases, rather than correcting them.
Yeo says “safeguards start with data”.
Certara emphasises reproducibility and clear documentation, allowing every assumption to be reviewed, and works closely with regulators, clinicians, and patient advocates.
“Trust grows through representation and openness,” she continues.
“Patients need to see that the data behind digital twins includes people like them, and that models continue to be refined with clinical and real-world evidence.
“Clear communication about how the models work and why they matter helps show that these tools are designed with patients in mind.
“By involving women directly, researchers can ensure the models address concerns that matter most, from pregnancy safety to postpartum care.
“When women see that their priorities influence science, they are more likely to trust and benefit from it.”
Accelerating innovation
Having more inclusive datasets will also accelerate innovation in femtech, ensuring developers design new diagnostic tools and therapies for women’s health based on representative science, while data and insights collected through biosimulation can potentially shorten the timeline to regulatory approval.
“Femtech innovation depends on evidence that reflects women’s realities,” says Yeo.
“Digital twins make this possible by generating early data where traditional studies fall short.”
According to Yeo, AI is already having an impact on diversity in clinical trials, with regulators encouraging trial designs that use biosimulation to fill data gaps.
She believes digital twins could become a standard part of trial planning to ensure underrepresented groups are included within the next five years.
“Inclusivity will take time, but the momentum is here. Each step toward more representative datasets and more confident dosing guidance brings us closer to equitable clinical research.”
So what does success look like? That depends on the stakeholder, says Yeo.
For Yeo and her team, it’s being able to generate virtual subjects that reflect the characteristics of the patients receiving the medicine, giving a more realistic view of how therapies perform in practice.
For regulators, it’s the ability to approve drugs with confidence that dosing and safety information work across diverse groups.
And for patients, it is the assurance that the evidence was generated with their needs in mind.
“Success is not about technology alone,” adds Yeo.
“But about the trust and outcomes it creates for people who were once excluded.”
Pregnant women’s expectations about postpartum sleep may predict sleep quality after birth, outweighing prior sleep and psychiatric history, a study suggests.
The findings suggest attitudes and beliefs about sleep during pregnancy could be a modifiable risk factor for postpartum sleep concerns.
They also indicate that, among women expecting the poorest sleep, higher postpartum anxiety may further worsen sleep quality.
Sammy Dhaliwal, lead author is clinical health psychologist and research fellow in the department of obstetrics and gynaecology at the Perelman School of Medicine at the University of Pennsylvania.
Dhaliwal said: “Most pregnant women in our sample anticipated poor postpartum sleep before it occurred, and it was striking that those expectations predicted worse sleep outcomes even after accounting for factors such as prior sleep disorders, psychiatric history, and number of previous births.
“This suggests that attitudes and beliefs about sleep during pregnancy may represent a modifiable target for early intervention before postpartum sleep problems emerge.”
Sleep disturbance affects an estimated 60 to 80 per cent of postpartum women and is linked to a higher risk of depression and anxiety.
Researchers said it is often regarded as an expected part of life after childbirth rather than a health issue that may be addressed earlier.
The study enrolled 432 pregnant women at about 24 weeks of gestation, meaning around 24 weeks into pregnancy.
Participants completed measures of their expectations about postpartum sleep, current sleep quality using the Pittsburgh Sleep Quality Index, and mood using validated depression and anxiety scales.
Assessments were repeated at six, 12 and 24 weeks postpartum.
A subset of 49 women also wore wrist actigraphy devices at six to eight weeks postpartum.
Actigraphy uses a wearable device, similar to a watch, to estimate sleep and wake patterns based on movement.
The results showed that 70 per cent of pregnant women, or 301 of 432 participants, expected poor sleep in the postpartum period.
Researchers found that predicted sleep disruption during pregnancy was a significant predictor of postpartum sleep concerns.
Among first-time pregnant women without prior health concerns, those who expected greater sleep disturbance had significantly more disrupted sleep after birth, measured by both actigraphy and self-report.
Among women who expected the worst sleep quality, higher postpartum anxiety significantly worsened both measured sleep and self-reported sleep, independent of anxiety levels during pregnancy.
Dhaliwal said the findings point to two possible areas for intervention: addressing sleep-related beliefs during pregnancy and treating postpartum anxiety.
Dhaliwal said: “Postpartum sleep disruption is often treated only after problems develop, but our findings suggest there may be an opportunity to intervene earlier during pregnancy.
“Addressing sleep-related beliefs and postpartum anxiety during prenatal and postpartum care may help improve sleep and emotional well-being in new mothers.”
A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.
The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.
It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.
The work forms part of the ongoing RESTORE clinical trial.
Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.
“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.
“This medication is incredibly promising when someone responds with 10 per cent weight loss.”
The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.
PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.
Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.
Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.
The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.
Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.
Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.
Endocrinologists are doctors who specialise in hormones and hormone-related conditions.
Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.
“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”
The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.
Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.
Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.
The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.
The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.
Entrepreneur
Women’s Health Week Europe 2026 opens pitch applications for mainstage showcase at The Emirates Stadium
Women’s Health Week Europe 2026 has opened applications for its flagship start-up Pitches, giving women’s health innovators the chance to present on the mainstage at The Emirates Stadium in London on 7-8 October.
16 finalists will be selected across two categories: Medical Devices & Therapeutics and Consumer & Tech, with the shortlisted companies receiving the opportunity to pitch in front of 700+ investors, corporates, other innovators and strategic partners actively seeking solutions that can scale.
Two categories, one stage
The Medical Devices & Therapeutics category is open to companies working across medical devices, therapeutics and pharma innovation, regulated digital health, and deep-tech or science-led platforms.
The Consumer & Tech category covers consumer health and wellness brands, digital health platforms, wearables and connected data, employer and payor-led solutions, and commerce and marketplace businesses.
Any company treating a condition that affects women exclusively, differently, or disproportionately is eligible to apply.
Applications are completely free, so what do you have to lose?
Apply to pitch at WHW Europe 2026 now.
What’s in it for you?
Unmatched exposure
Present in front of 700+ investors, corporates, clinicians, and strategic partners actively seeking solutions that can scale.
With WHW Europe 2026 relocating to The Emirates Stadium and expanding to 700+ attendees across two stages, the 2026 edition represents the largest platform the series has offered to date.
A proven platform
The WHW Pitch Sessions have become one of the most commercially significant showcases in women’s health, with previous cohorts including companies that have gone on to raise investment and secure major strategic partnerships. 2024 alumni BoobyBiome, closed a £2.5M seed round in the year following their pitch at WHW Europe.
The Watchlist
All registered applicants will have the opportunity to be featured in The Watchlist, WHW Europe’s official directory of women’s health innovators to know, giving companies visibility beyond the pitch stage itself.
Applications close 28 August 2026.
Find out more about WHW Europe.
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