News
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.”
Mental health
Yoga and omega-3 as effective as therapy for depression in pregnancy, research finds

Yoga and omega-3 supplements may be as effective as talking therapies for pregnancy depression, a major review suggests.
Globally, nearly one in three pregnant women experience depression, but most receive no treatment.
When support is available, women are often directed towards talking therapies such as cognitive behavioural therapy, or CBT, and mindfulness.
CBT is a structured talking therapy that helps people identify and change patterns of thought and behaviour affecting their mental health.
The review examined 115 clinical trials involving more than 12,000 participants across 30 countries.
It found that yoga, massage, omega-3 supplements and bright light therapy were broadly as effective as talking therapies at reducing depression symptoms during pregnancy.
Bright light therapy involves controlled exposure to bright light and is sometimes used to treat mood conditions.
The findings point to the importance of social support and increased connection, as all these approaches offer some element of contact or guided support.
Led by King’s College London, the research brought together trial evidence across every type and format of treatment for antenatal depression under a common framework.
Antenatal depression is depression that occurs during pregnancy.
The study was conducted as part of HappyMums, a European consortium led by the University of Milan that aims to improve mental health support during pregnancy and after birth.
Carmine Pariante, professor of biological psychiatry, said: “This is the most comprehensive analysis of treatments for depression in pregnancy ever conducted, and the findings should prompt a rethink of how we support women during this critical period.
“The evidence is clear that there is no single best approach. What matters is that women have access to a range of options, and that clinicians feel equipped to offer them.”
The researchers said yoga and omega-3 supplements could be legitimate treatment options, rather than stopgaps, for women on waiting lists or those who struggle to access mental health support.
However, the studies differed considerably in design, sample size and how results were measured, so the findings should be interpreted with care.
The team said non-psychological approaches could help women cope with long waits for care without ruling out other treatments alongside them.
Digital and online interventions, including apps and telephone-based support, were also found to be as effective as face-to-face treatment.
Researchers said this could affect how antenatal depression is managed, particularly for women who cannot travel or face long waits for in-person care.
The team found no randomised controlled trials of pharmaceutical treatments for antenatal depression, despite antidepressants being widely prescribed for depression outside pregnancy.
A randomised controlled trial is a study in which participants are randomly assigned to different treatment groups, allowing researchers to compare outcomes more fairly.
Evidence for drug treatment during pregnancy therefore relies on indirect research rather than trials carried out during pregnancy, reflecting long-standing caution around testing medicines in pregnant populations.
NICE guidelines recommend antidepressants for moderate to severe depression in pregnancy, while evidence from outside formal pregnancy trials suggests they can be safe and effective.
However, the researchers said trials are still needed, particularly for women who cannot access or engage with other forms of support.
Riddhi Laijawala, trial manager and PhD student, said: “Depression in pregnancy is common, but it is not inevitable, and it is treatable. What this review shows is that the options available to women are broader than many people realise.
“A yoga class, music therapy, or an online programme may not sound like clinical treatment, but the evidence suggests they can make a real difference, and for many women they may be easier (and quicker) to access than a course of therapy.”
Depression during pregnancy affects an estimated 28.5 per cent of pregnant people worldwide, but only around one in five receives appropriate and timely treatment.
The team said closing this treatment gap should be a priority for health systems because the condition can affect both parent and child.
The HappyMums project is supported by the European Union’s Horizon Europe research and innovation programme.
Hormonal health
Type 2 diabetes rising among young women, experts warn

Type 2 diabetes is rising among women in their 20s in England, with experts warning of a worrying increase since the Covid pandemic.
The rise has largely occurred since the pandemic and is closely linked to increasing obesity levels, according to an analysis of NHS data from 2011 to 2024.
The condition is serious and can lead to severe complications, including heart attacks and strokes.
Diabetes UK said it tends to be more aggressive when it develops at a younger age, raising the risk of serious complications and shorter lives.
The charity said early diagnosis is vital for people at risk to help prevent long-term organ damage.
The condition can sometimes be put into remission through healthy eating and maintaining a healthy weight, without relying on glucose-lowering medicines.
Researchers said newer obesity treatments, including GLP-1 injections and pills, may also help alongside healthy eating advice.
About 90 per cent of the six million people living with diabetes in the UK have type 2 rather than type 1, or insulin-dependent, diabetes.
The risk increases with age, and older adults still account for the largest proportion of new diagnoses.
However, NHS England estimates suggest that 12,000 people under 30 are now living with the condition, with women making up more of the younger cases.
Common symptoms include feeling very tired, urinating more often than usual and feeling thirsty all the time.
Researchers at Imperial College London analysed NHS data from the English National Diabetes Audit to examine trends over time.
The figures showed that cases are falling slightly among older adults, who still account for the largest share of new diagnoses.
However, diagnoses are increasing rapidly among people under 40, with some of the sharpest rises among women aged 20 to 29.
Body mass index at diagnosis has also been rising more quickly among younger adults than in older age groups, pointing to obesity as a likely factor.
Body mass index, or BMI, is a measure of obesity based on a person’s height and weight.
Separate NHS data for England shows obesity rates have worsened since the pandemic, with nearly one in three people now affected.
The largest increases over time have been among younger adults.
Between 2019 and 2025, new obesity cases rose by 16 per cent among people aged 20 to 29 and by almost 20 per cent among those aged 30 to 39.
Rates fell among adults aged 60 to 79 over the same period.
Lead researcher Dr Shivani Misra said: “We think that the earlier onset of severe obesity in young people is increasing their type 2 diabetes risk in early life and pulling down their age at diagnosis.
“This is really worrying given the poor health outcomes from early-onset type 2 diabetes.”
Misra said much of the discussion about rising rates among younger people had focused on ethnic minority groups, which have traditionally been considered at higher risk.
However, the new data suggests the trend extends well beyond those communities.
She added: “We now see that incidence is also increasing in white populations too, showing that this public health challenge is broadening across the generations.”
Diabetes UK said better follow-up care is also needed for mums-to-be diagnosed with gestational diabetes during pregnancy because it raises the risk of developing type 2 diabetes after childbirth.
Some studies have suggested that the risk of developing the condition may also increase after being ill with Covid, although the evidence remains inconclusive.
Wellness
AstraZeneca drug approved for breast cancer in EU

AstraZeneca’s breast cancer drug Etcamah has been approved in the EU as part of a combination treatment for advanced disease.
The European Commission acted on a positive opinion from the Committee for Medicinal Products for Human Use, the Cambridge, England-based drug maker said.
The decision followed positive results from the Serena-6 phase III trial, which showed a 56 per cent reduction in the risk of disease progression in advanced oestrogen receptor-positive breast cancer.
A phase III trial is a large, late-stage study used to assess a treatment’s safety and effectiveness before wider regulatory approval.
Oestrogen receptor-positive breast cancer is a form of the disease that can grow in response to the hormone oestrogen.
Etcamah, whose generic name is camizestrant, was tested in combination with a cyclin-dependent kinase 4/6 inhibitor.
Known as CDK4/6 inhibitors, these medicines block proteins that help cancer cells grow and divide.
AstraZeneca said the Etcamah combination has also been approved in Japan, the UAE and Saudi Arabia based on the Serena-6 trial results.
The company said breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and more than 540,000 patients diagnosed in 2024.
AstraZeneca shares were down 0.6 per cent at 12,628 pence in London on Thursday.
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