Cancer
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?
An experimental cancer drug reduced bone loss and body fat in mice modelling post-menopausal changes, early research suggests.
The compound, CADD522, appeared to strengthen bones and help the animals stay leaner after surgery designed to mimic hormonal changes seen after menopause.
The treatment remains at an early experimental stage and has so far only been tested in animals.
The study, led by the University of East Anglia, investigated CADD522, which was originally developed to block a protein involved in the growth and spread of several cancers.
Mice treated with the compound for eight weeks showed significant improvements in bone health. Scans found increased bone volume and better preservation of the honeycomb-like structures inside bones that are crucial for strength and resilience.
Blood tests suggested the treatment stimulated new bone growth without interfering with the body’s normal process of breaking down and rebuilding bone.
Dr Darrell Green, lead researcher from UEA’s Norwich Medical School, said: “Osteoporosis affects around one in three women over the age of 50, leaving sufferers vulnerable to painful fractures that can seriously impact quality of life.
“Current treatments exist, but many are plagued by side effects, safety concerns or inconvenient dosing schedules that make long-term use difficult.”
The researchers also found that mice receiving CADD522 weighed less than untreated mice despite eating the same amount of food.
They had less body fat and fewer fat deposits in their bone marrow, a process commonly seen after menopause and linked to declining bone health.
The team also examined brain tissue and found that the drug appeared to reverse several menopause-related changes in fatty acids.
Levels of omega-3 fats including DHA remained largely intact, while several other lipid abnormalities shifted back towards healthier patterns.
Green said: “We didn’t directly test for memory or thinking ability, but our work raises questions about whether this drug could one day help address wider menopause-related health problems.”
Safety experiments in mice, rats and dogs found that CADD522 could be taken orally and was well tolerated.
The compound also appeared to be metabolised more slowly in human tissue than in rodents, potentially improving its performance in people.
“This is still in the early stages and has so far only been tested in animals but we hope that the benefits will translate to humans to ultimately reduce fracture rates,” added Green.
The research was led by UEA in collaboration with the University of Maryland, the Scintillon Research Institute in San Diego and the University of Stirling.
Safety testing was funded by The Sir William Coxen Trust as part of the development of CADD522 as a childhood cancer treatment.
The FDA has granted accelerated approval to AstraZeneca drug Etcamah for certain adults with advanced breast cancer carrying an ESR1 mutation.
Etcamah, also known as camizestrant, was approved in combination with a CDK4/6 inhibitor, either abemaciclib, palbociclib or ribociclib.
The treatment is for adults with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer when an estrogen receptor-1 (ESR1) mutation is detected during aromatase inhibitor and CDK4/6 inhibitor therapy using an FDA-authorised test.
ESR1 mutations are acquired resistance mutations that tumours may develop during treatment with aromatase inhibitors, a type of endocrine therapy commonly used as a front-line treatment for locally advanced or metastatic breast cancer.
Fewer than 5 per cent of patients have the mutation when HR-positive metastatic breast cancer is diagnosed, according to the FDA. After disease progression on an aromatase inhibitor, nearly 40 per cent have the mutation.
Acting FDA commissioner Kyle Diamantas said: “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment.
“We owe them every weapon in our arsenal.
“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
The accelerated approval programme allows earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints.
For Etcamah, approval was based on how long patients lived without their disease worsening, measured from when the resistance mutation was first detected in their blood.
The FDA said it has not yet been confirmed whether intervening when the mutation is detected, rather than waiting until disease progression is confirmed, results in a clinically meaningful benefit. Confirmatory studies are therefore required to verify and describe clinical benefit.
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said: “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.
“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing.
“But additional evidence is needed to confirm clinical benefit.”
Circulating tumour DNA, or ctDNA, consists of small pieces of tumour DNA released into the blood and can allow earlier molecular detection of resistance mutations.
The FDA also authorised the Guardant360 CDx assay as a companion diagnostic to identify patients with breast cancer who have ESR1 mutations for treatment with camizestrant.
Efficacy was assessed in a clinical trial comparing a switch to Etcamah plus a CDK4/6 inhibitor with continued treatment using an aromatase inhibitor plus a CDK4/6 inhibitor.
Estimated median progression-free survival was 16 months in the Etcamah group, compared with 9.2 months in the aromatase inhibitor group.
Etcamah’s prescribing information includes a boxed warning about the risk of irregular heart rhythm when taken with certain other medicines. It also includes warnings about an abnormally slow heart rate and potential harm to an unborn baby.
The FDA convened its Oncologic Drugs Advisory Committee for the application on 30 April 2026.
Scotland has launched a review of NHS IVF access, including whether treatment should extend to single women and couples with children from previous relationships.
The national review will assess how fertility services can better reflect modern family structures while maintaining fair and consistent access across Scotland.
It will also examine access to fertility preservation services, particularly for women who have undergone cancer treatment, and ways to cut waiting times for patients who need donor eggs or sperm.
Scotland currently offers the most comprehensive nationwide NHS IVF provision in the UK. Eligible patients can access up to three full cycles of IVF treatment through the NHS, subject to existing eligibility criteria.
Ministers will also consider updated clinical guidance from the National Institute for Health and Care Excellence.
The revised recommendations suggest patients who have not achieved a successful pregnancy after three IVF cycles could benefit from up to three additional NHS-funded treatment cycles.
The review is part of the Scottish Government’s commitment to examining how fertility services are delivered and whether they meet patients’ needs across Scotland.
Scottish health secretary Angela Constance said: “Access to NHS IVF treatment should be fair, timely and reflect the way people’s lives and families look today, and delivering this review is one of our key 100 day commitments.
“The review will look closely at the current system, including waiting times for those who need donor eggs or sperm for their treatment.
“This work builds on annual Scottish Government funding, which has supported the expansion of NHS IVF treatment over the past ten years.”
Healthcare leaders and fertility specialists will be watching closely as the review progresses, with any future changes potentially broadening access to treatment and addressing long-standing concerns around equity, consistency and waiting times.
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