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Could FemTech Help Close the Gender Gap in Clinical Research?

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Medical research has shaped the treatments and healthcare practices used today. However, historically, it has failed to account for sex-based differences in disease presentation, treatment responses, and overall health outcomes. For decades, women have been underrepresented in clinical trials, which has resulted in gaps in medical knowledge that affect everything from drug efficacy to disease management.

Don’t believe it? Recent studies highlight the extent of the issue, as a 2023 report from the British Medical Journal revealed that only 41% of participants in UK-based clinical trials were female. Sadly, many trials still exclude women due to concerns over hormonal fluctuations, leaving medical professionals without accurate data on how treatments impact half the population. Without action, misdiagnoses, ineffective treatments, and higher rates of adverse drug reactions will continue to affect women’s health.

The rise of FemTech—technology designed to address women’s health needs—offers a potential solution. Thanks to leveraging digital tools, AI-driven data collection, and real-world evidence, FemTech is reshaping clinical research and paving the way for gender-inclusive healthcare advancements, and here’s how.

The Gender Gap in Clinical Research: Where Are We Now?

Women continue to be underrepresented in clinical research, with disparities persisting across multiple medical fields. Cardiovascular disease, for example, is the leading cause of death among women in the UK. Despite this, a 2023 report from the British Cardiovascular Society highlighted that women are significantly less likely to be included in trials for new treatments. Research into conditions that predominantly affect women, such as endometriosis and polycystic ovary syndrome (PCOS), also remains underfunded, leading to prolonged diagnostic delays and limited treatment options.

Recent regulatory efforts aim to improve representation. The European Medicines Agency has updated its guidelines to require more sex-specific data analysis in clinical trials. However, implementation remains inconsistent, with many research institutions yet to adopt clear policies ensuring equal representation. Without systemic changes, women will continue to receive medical treatments developed using incomplete or male-biased data, increasing the risk of misdiagnoses and inadequate care.

Leveraging Education and Awareness to Drive Change

Of course, public awareness plays a critical role in addressing research disparities. Many healthcare professionals lack training in gender-specific medicine, contributing to diagnostic delays and ineffective treatments. Universities can bridge this gap by integrating women’s health topics into university courses, ensuring future medical professionals are equipped to challenge outdated practices.

What about those looking to specialise in this field? Fortunately, there are plenty of opportunities, making it possible to find a degree course at a UK university that focuses on gender-inclusive research and digital health advancements. Widespread education efforts, including public health campaigns and professional training, will drive long-term improvements in research inclusivity.

Addressing Bias in Medical Trials Through Technology

Sadly, bias remains a persistent issue in clinical trials. Women are often excluded from research due to concerns over hormonal variability, yet this exclusion leads to incomplete medical knowledge. A study published in the American Journal of Medicine found that women are underrepresented as participants, authors, lead authors, and leadership committees in cardiovascular randomised controlled trials (RCTs), limiting the ability to perform sex-disaggregated analysis and generalise findings to women.

AI and machine learning tools can help correct these disparities. Algorithm-driven trial design ensures balanced participation by identifying gaps in enrolment and recruiting diverse populations. Integrating FemTech data further strengthens this approach by capturing real-world insights into conditions that disproportionately affect women, such as endometriosis and autoimmune disorders.

The Role of Digital Health in Personalised Research

Personalised medicine is transforming healthcare, with digital health tools accelerating this paradigm shift. Standard treatments often fail to account for individual differences in genetics, hormones, and lifestyle factors. With AI-driven diagnostics and wearable technology becoming increasingly sophisticated, medical professionals can develop treatments tailored to an individual’s unique biology.

Recent advances demonstrate the potential impact of this approach. Research published in the Journal of Clinical Endocrinology & Metabolism shows that AI and machine learning approaches can significantly improve the prediction of menopause timing compared to traditional methods. These insights enable more proactive management of symptoms and better long-term health outcomes—a significant advancement in women’s healthcare.

Regulatory Challenges and Opportunities for FemTech Solutions

Integrating FemTech into mainstream healthcare requires navigating complex regulatory frameworks. Historically, digital health solutions faced challenges due to stringent approval processes. However, the MHRA has introduced initiatives to address these issues.​

In January 2024, the MHRA published its roadmap for delivering a future regulatory framework for medical devices. This roadmap aims to provide consistency, clarity, and continuous improvement, fostering a more supportive environment for medical technology innovations, including FemTech. ​

Additionally, the Innovative Devices Access Pathway (IDAP) pilot was launched to reduce uncertainty in the route to market for technology developers. This initiative stems from the Life Sciences Vision, aiming to enable and improve patient access to innovative and transformative medical devices by providing integrated regulatory and access support to developers. These efforts indicate a shift towards a more accommodating regulatory environment for FemTech solutions, enhancing their potential to be integrated into mainstream healthcare.​

Policymakers are also focusing on creating a thriving life sciences sector. The UK’s Life Sciences Vision outlines plans to stimulate the sector, address significant healthcare challenges, and emphasise the integration of innovative technologies. ​Advocating for FemTech’s inclusion in clinical research guidelines and leveraging these supportive regulatory frameworks will ensure these innovations reach the patients who need them most.​

How Data-Driven Innovation Could Improve Outcomes for Women

Leveraging big data is essential to closing the gender gap in healthcare. By aggregating information from FemTech applications, researchers can develop more precise treatment strategies tailored to female biology. This approach has the potential to reduce misdiagnosis rates and ensure medical advancements serve women more effectively.​

Collaboration between FemTech companies, academic institutions, and healthcare providers is already driving change. For instance, AI-powered virtual assistants are being developed to provide personalised support and information related to menopausal symptoms. In 2024, Mira Care launched its AI-powered ‘Menopause Transitions Kit’ for at-home hormone monitoring, allowing users to track key reproductive hormones and personalise menopause management accordingly. ​

These advancements highlight how data-driven innovation is leading to more personalised, effective treatments for women. Increased investment in FemTech collaborations could further refine diagnostic tools and ensure that medical research reflects the full spectrum of female health experiences.

Embracing these technological advancements and fostering collaborations means the healthcare industry can make significant strides toward closing the gender gap in clinical research and treatment outcomes.​

Encouraging Greater Female Participation in Clinical Studies

Many women remain unaware of opportunities to participate in clinical trials. FemTech platforms can help by providing personalised trial recommendations based on a user’s health profile. Ensuring flexible study designs, offering compensation, and addressing safety concerns can further encourage participation. More inclusive trials mean better data, leading to improved medical treatments for women.

Driving Lasting Change in Medical Research

FemTech is reshaping how women’s health is studied, offering a powerful tool to close research gaps and improve healthcare outcomes. With continued investment, regulatory support, and public engagement, these innovations will drive lasting change in clinical research, though institutional adaptation may require sustained effort.

The transition towards inclusive, data-driven healthcare requires coordinated action across multiple sectors. Researchers, policymakers, and technology leaders must collaborate to ensure medical studies reflect the needs of all patients, not those who align with traditional research parameters. Strengthening these efforts will not only advance women’s healthcare but also enhance the quality and applicability of medical research overall—creating a more equitable and effective healthcare system for everyone.

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Wellness

Weekly app monitoring reduces breast cancer fatigue, study shows

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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.

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Fertility

Higher doses of common fertility drug may increase pregnancy risks

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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.”

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Entrepreneur

Women’s Health Week Europe 2026 releases fully populated agenda ahead of October summit

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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.

Apply to pitch

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