News
Shrinking the gender health gap through innovation in clinical trial AI

By Paula Bellostas Muguerza, Global Lead, Healthcare and Life Sciences at Kearney
The lack of female representation in clinical research is finally getting the recognition it deserves as a driving factor of the gender health gap.
With only 7 per cent of healthcare research focused on conditions that exclusively impact women’s health, it’s an area that has frustratingly been overlooked and underfunded for decades.
Clinicians have been forced to make decisions about women’s health based on limited data and male-centric trials.
As a result, women are routinely subjected to missed diagnoses and delayed treatments.
However, like nearly every sector, AI is reshaping healthcare, and if used correctly, there’s a real opportunity to redesign clinical trials, close long-standing gaps, and make research far more inclusive and effective.
Incorporating AI
Unlocking innovation in women’s health, including more diverse women in clinical trials, disaggregating data by sex, redesigning clinical trials with women in mind, and deepening insights on sex differences were all recognised as core principles for improving healthcare policy in the World Economic Forum’s recent “Prescription for Change” white paper, in collaboration with Kearney and the Gates Foundation.
This focus is critical in improving healthcare outcomes for women.
Conditions such as heavy menstrual bleeding, endometriosis, fibroids, and ovarian cysts cost the UK economy approximately £11 billion per year, but fixing the gaps in treatment and trials goes beyond profit – it’s our moral duty.
And to unlock innovation at scale, policymakers should pair regulatory incentives with financing tools like targeted tax credits and dedicated grant programmes.
However, shrinking the gender health gap will take more than good intentions.
Clinical trials still face a range of issues, from under-reported side effects to low female participation. AI can help by improving how data is captured, making trials more inclusive and leading to fairer, higher-quality outcomes.
According to the National Centre for Biotechnology (NCBI), AI’s ability to analyse complex and diverse information allows for an improved understanding of gender differences, leading to more effective treatments for women in the future.
The World Economic Forum’s push to expand inclusion in clinical trials by involving more women highlights the importance of raising awareness among regulators and trial teams.
Inclusion must be prioritised in the early phases of trials, particularly in cardiology and oncology, and extended to underserved groups, including women of colour and post-menopausal women.
Attitudes to inclusion are also moving in the right direction, and AI can help drive that momentum.
By analysing large datasets, advanced algorithms can identify underrepresented women for targeted recruitment, leading to more representative trials.
AI can also review trial protocols to detect potential gender bias and recommend designs that address gender-based differences and women’s specific health needs.
Approach with caution

Paula Bellostas Muguerza
Although AI offers powerful capabilities, it’s not a fail-safe tool, and the need for human oversight has never been more important.
Models trained on biased data risk repeating existing inequalities, especially when sex-based differences in conditions like heart disease, stroke, and neurological disorders are still underrepresented in many datasets, leading to fatal consequences.
In doing so, AI could reinforce the very misconceptions about women’s health it’s meant to correct.
A study by the London School of Economics and Political Science (LSE) found evidence that AI tools are more likely to downplay women’s health issues compared to men’s. The increasing use of AI models by local authorities to supplement the workload of social workers across the country could result in widespread unequal care provision, perpetuating the gender bias.
The recommendation for researchers, clinicians, and developers to enhance sex-disaggregated data is especially relevant here.
Without data that clearly captures sex and gender differences, AI systems can’t be expected to recognise or respond to them accurately.
This requires standardised collection methods and consistent terminology so women’s health signals are properly captured and acted upon.
Healthcare organisations process huge amounts of data containing important clinical information, spread out and stored in different formats.
Improving the way data is captured makes clinical trials more inclusive and produces fairer, higher-quality results.
AI can combine structured and unstructured data, turning clinical records into meaningful and actionable insights.
AI regulation also varies wildly across countries.
The EU’s AI Act is one of the first major attempts to introduce clear rules, but elsewhere, regulation remains patchy.
While pharmaceuticals go through rigorous testing and approval processes, AI-driven tools often slip through regulatory gaps.
That’s why it’s even more important to design inclusive clinical trials from the start, ones that properly capture sex and gender differences and feed better data into these systems from the outset.
Mind the gap
Having reached crisis status, the task of reducing the gender healthcare gap can appear overwhelming.
But despite the scale of the challenge, there are real reasons for optimism.
We’re already seeing progress, and growing pressure from researchers, investors, and campaigners is pushing the system in the right direction.
But progress won’t come from technology alone. Transparency and inclusivity are just as important.
AI systems must be developed through processes that involve patients, clinicians, community advocates, as well as data scientists and engineers.
This kind of collaborative participation will help highlight blind spots, challenge assumptions, and build tools that reflect the complexities of healthcare, ultimately dispelling the one-size-fits-all myth.
If AI is going to play a role in closing the gender health gap, it must be guided by more than innovation.
Yes, we’re making technological breakthroughs, but if they simply replicate the inequities of the past, what use are they?
Wellness
Weekly app monitoring reduces breast cancer fatigue, study shows

Weekly app monitoring can reduce fatigue and improve daily life for women with metastatic breast cancer, according to a study.
The approach involves regularly asking patients about their wellbeing through an app and responding quickly when problems are identified.
Germany’s Federal Joint Committee, known as the G-BA, has recommended that the treatment model be incorporated into standard care.
Professor Maria Karsten, senior attending physician at the Charité Breast Cancer Center and initiator of the PRO B project, said: “The new medications often no longer need to be administered at the hospital but can be taken at home.
“As a result, we see patients less frequently at the hospital, and our medical oversight has become somewhat incomplete.
“In order to close this gap and provide patients with close support in spite of the distance, we have developed the PRO B digital treatment concept.”
Around 68,000 women in Germany are living with metastatic breast cancer, meaning the disease has spread to other organs.
At this stage, the cancer is generally considered incurable. Modern treatments can, however, temporarily control the disease and extend life expectancy by several years, with some women able to continue working.
At the centre of PRO B is an app that asks women up to 52 structured questions once a week about their symptoms, daily life and emotional wellbeing.
Questions include whether they have experienced pain, felt too tired to carry out their usual activities or experienced shortness of breath.
An algorithm analyses the answers and immediately alerts the treatment team when relevant changes are detected.
The team then contacts the patient within 48 hours to decide whether any action is needed.
Karsten said: “During these phone calls, for example, we discuss whether the dosage of anti-nausea medication should be adjusted or offer practical tips for managing the various symptoms.
“But we also detect serious side effects more quickly – such as those indicated by a seemingly harmless symptom like fatigue – and can immediately schedule the patient for an appointment at the hospital.”
The study involved 909 women with metastatic breast cancer aged 19 to 81 across 52 breast cancer centres in Germany and followed them for one year.
Around half received PRO B care alongside drug-based cancer treatment.
The other half answered questions about their wellbeing once every three months and were not contacted by their treatment teams in response.
Women receiving PRO B care reported significantly less fatigue, which refers to physical, emotional or mental exhaustion that can severely restrict daily life.
They also rated their physical functioning more positively and required fewer hospital admissions.
Karsten said: “These are effects that have a noticeable impact on the patients’ daily lives; the women are more capable and better able to manage their lives.
“We even have evidence that the PRO B approach extends the remaining lifespan for some patients. We are achieving all of this not through a new medication, but simply by regularly and systematically assessing the women’s well-being and responding accordingly.”
More than 90 per cent of women in the PRO B group said after the study that they wanted the approach to become part of routine care.
Stephanie Neumann-Johnston, 51, who took part in the study, said: “I feel like the app has saved my life several times.
“There are so many situations and incidents that you can’t make sense of – you have so many questions.
“With the app, I can look up common problems and find medically reviewed information, for example, about fatigue. That way, I can help myself, also on the weekends.
“And the personal contact provides me with emotional and medical support.
“For example, I can find out whether I’m allowed to take certain medication for a fever, or get an assessment of my situation: Should I go to the emergency department with these symptoms or not? The app takes a huge weight off your shoulders.”
Based on the medical findings and a health economic analysis, the G-BA recommended in June that PRO B should be incorporated into standard care.
This would allow patients with statutory health insurance to access the model in future when they receive the relevant diagnosis.
PD Dr Christoph Kowalski, department director at the German Cancer Society and a co-author, said: “This recommendation must now be implemented as quickly as possible.
“If a new care concept offers medical and economic benefits, we should not withhold it from the most seriously ill women.”
The health insurance companies involved in the project are also planning further developments so affected women can receive routine PRO B care before its wider introduction into standard care, with access expected to begin this autumn.
The care model will continue under the name “ida”, led by Karsten and her team.
The PRO B project ran from 2020 to 2024 and received around €4.8m from the Innovation Committee of the Federal Joint Committee.
The project was led by Karsten, with consortium partners BARMER, mkk – meine krankenkasse, DAK-Gesundheit, the German Cancer Society and OnkoZert GmbH.
Breast cancer is the most common cancer among women in Germany, with around one in eight expected to develop the disease during their lifetime.
Worldwide, breast cancer is the leading cause of cancer-related deaths.
Despite advances in treatment, 30 per cent of women with early-stage breast cancer and up to 70 per cent of those with lymph node involvement in later stages develop distant metastases, which typically make the disease incurable.
For patients with metastatic breast cancer, treatment aims to prolong life while maintaining the best possible quality of life.
Since 2016, the G-BA has been responsible for supporting new forms of care that go beyond existing standards, as well as health services research aimed at improving healthcare quality in Germany.
Its Innovation Fund is financed through contributions from statutory health insurance plans and the Health Fund.
Fertility
Higher doses of common fertility drug may increase pregnancy risks

Higher cumulative doses of common fertility drug clomiphene citrate may increase pregnancy loss risks, according to new research.
Around one in six people experience infertility, with irregular or absent ovulation among the most common causes.
Clomiphene citrate has long been a mainstay of fertility treatment, but Adelaide University research has raised concerns about higher cumulative doses.
The new study found that high doses of clomiphene citrate accumulated over multiple fertility treatment cycles could increase the risk of pregnancy loss.
Lead author associate professor Sheree Boulet said the findings showed a clear dose-response relationship, meaning the risks increased as cumulative exposure rose.
She said: “Women who received higher cumulative doses of clomiphene citrate experienced progressively greater risks of adverse pregnancy outcomes.
“We examined more than 21,000 embryo transfer cycles across four cumulative dose categories and found that increasing the dose did not significantly improve the chance of a live birth.
“Our findings suggest there may be a point where increasing the dose offers little additional benefit while exposing women to greater risk, highlighting the importance of carefully balancing effectiveness with safety when making treatment decisions.”
Supported by the NHMRC and conducted in partnership with Boston University and the Centers for Disease Control and Prevention, researchers analysed 21,004 IVF embryo transfer cycles in the US.
Women receiving cumulative doses of 500mg to 749mg of clomiphene citrate had a 12 per cent higher risk of miscarriage, while those receiving 750mg to 999mg had a 38 per cent higher risk.
Women receiving cumulative doses of 750mg or more were also more than twice as likely to have twins or other multiple births.
Rates of spontaneous abortion, another term for miscarriage, increased as the dose rose.
Researchers also recorded more than a threefold increase in stillbirth at the highest dose, although the finding was not statistically significant because that dose was rare. Larger studies are needed to confirm the association.
The finding is consistent with an earlier Adelaide University study that showed a doubling of neonatal death in pregnancies involving clomiphene citrate. Neonatal death means the death of a baby shortly after birth.
Higher cumulative doses did not improve the chance of a live birth, but did increase twinning, which raises the risk of adverse outcomes for both mother and child.
Clomiphene citrate is one of the world’s most widely prescribed fertility drugs. It has been prescribed to millions of women worldwide since 1967 and remains a recommended first-line treatment for ovulation induction.
The drug is recognised as an essential medicine by the World Health Organization. It works by stimulating the ovaries to release eggs, increasing the chance of pregnancy.
Women who do not respond to lower doses, or who require multiple treatment cycles, may receive progressively higher cumulative doses over time.
The findings build on a series of studies from Adelaide University’s Robinson Research Institute linking clomiphene citrate with increased risks of pregnancy loss, stillbirth, perinatal death and some birth defects.
Experimental studies in mice supported these findings, showing that higher doses reduced successful pregnancies and were associated with pregnancy loss, impaired fetal growth and developmental abnormalities.
Professor Michael Davies, senior researcher and co-author of all the studies, said the latest work builds on more than two decades of Adelaide-led research into the safety of fertility treatments.
He said: “Clomiphene citrate has been used by many women since 1967, but it has never been comprehensively evaluated in large prospective clinical trials.
“Our studies indicate that women respond differently to clomiphene citrate and that increasing cumulative doses may increase the risk of adverse pregnancy outcomes without improving the likelihood of a live birth.
“The findings confirm and extend our previous studies in both human and mouse models which highlight the need to better understand the dose-response relationship and whether more personalised dosing strategies could improve safety.
“Until we can better understand these differences, it remains important that clinicians rigorously follow manufacturer’s safety recommendations and avoid unnecessarily increasing cumulative doses.
“The same questions are now being asked of newer ovulation-inducing medications, so any move away from clomiphene citrate should also be guided by robust evidence rather than assumptions about safety.”
Entrepreneur
Women’s Health Week Europe 2026 releases fully populated agenda ahead of October summit

Women’s Health Week Europe 2026 has released its fully populated speaker and session lineup ahead of the event’s return to The Emirates Stadium in London on 7–8 October, with 80+ speakers now confirmed across two dedicated stages.
The programme
The agenda runs across two dedicated stages in parallel, plus two pitch competitions across both days.
The Global Stage opens with a keynote from Merete Clausen (EIF) before moving into sessions on funding trends, AI, the gender data gap, the wearable revolution, and European policy.
Standout sessions include The Age of Digital TransformAItion featuring Nichole Young-Lin (Google), Frida Polli (MIT), and Sapna Shah (Sie Ventures); Lone Wolf or Pack Leader on collaboration versus fragmentation, with Eirini Rapti (Inne), Tatum Getty (Thena Capital), Novo Nordisk, and Jen Roberts-Woods (Borski Fund); and a live debate on whether the women’s health label helps or hinders founders. Day one closes with a keynote from Alison Cave, Chief Safety Officer at the MHRA.
The Scale Stage runs a practical playbook track in parallel, with sessions covering regulatory approval pathways, international expansion, the founder’s legal playbook, PR strategy, and implementing AI into a women’s health business.
The Reverse Pitch flips the usual format: investors and corporates pitch the room on what they are actively looking to fund, acquire, or partner on right now.
View the full agenda and speaker lineup
Pitch competitions
The WHW Europe pitch competitions are back, taking place in front of the audience across both days on the mainstage. 16 finalists will compete across two categories: Consumer & Tech on day 1 and Medical Devices & Therapeutics on day 2.
Any company treating a condition that affects women exclusively, differently, or disproportionately is eligible to apply.
Applications and close 28 August 2026.
Previous alumni include Circe, who secured £100k from Innovate UK, BoobyBiome, who closed a £2.5M seed round post-WHW Europe, and Amilis, who secured £1M at London Tech Week after winning at WHW USA 2026.
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