Dr Anita Phung, GP and medical monitor at Lindus Health, explains why the outdated model of medical research is holding women back — and how inclusive trials can unlock better science, stronger data, and more equitable care.

Today is Clinical Trials Day — a moment to recognise the vital role clinical research plays in advancing medicine. Yet, as we mark the occasion during Women’s Health Month, it’s clear there’s still progress to be made.

Women remain significantly underrepresented in clinical trials — with real consequences for safety, efficacy, and innovation. From endometriosis and autoimmune conditions to menopause, the lack of inclusive research data continues to undermine care.

Discover Pharma put several questions to Dr Phung.

How has the historical male-centric approach to clinical trials skewed the data we rely on today for diagnosing and treating women?

For much of medical history, women were treated as smaller versions of men. This bias has led to flawed research, frequent misdiagnoses, and inadequate care. Gaps persist in understanding conditions that uniquely or disproportionately affect women. Without robust data on how treatments interact with female biology, providers are left guessing — which can lead to ineffective or harmful outcomes.

“Women were treated as smaller versions of men — leading to flawed research, misdiagnoses, and inadequate care.”

Despite efforts since the late 1990s to improve female inclusion in trials, disparities remain — especially during key hormonal phases like menstruation, pregnancy, and menopause. These extend to conditions like cardiovascular disease, autoimmune disorders, and neurological conditions, where female-specific data is lacking.

Which areas are most urgently impacted by this underrepresentation — such as endometriosis, menopause, or autoimmune disorders?

Each is urgent in its own right. Endometriosis can cause chronic pain and infertility, yet is still under-researched, with diagnosis taking up to 8–10 years. As life expectancy increases, women may now spend half their lives in menopause — a stage still widely overlooked despite its impact on symptoms, cognition, and wellbeing.

Autoimmune diseases, more common in women, can cause chronic inflammation and increase risk of heart disease. Innovation is stalling not because one condition is more important than another — but because women’s health is consistently deprioritised across the board.

“Women make up half the global population. Ignoring their needs is a clinical failure and a missed commercial opportunity.”

From a commercial and clinical perspective, how is this underrepresentation limiting market potential for pharma companies?

Women make up half the global population. Ignoring their specific health needs isn’t just a clinical failure — it’s a missed commercial opportunity. Medications that work well in men may behave differently in women due to differences in physiology and hormonal states. Addressing this can improve treatment adherence, reduce side effects, and unlock entirely new therapeutic markets.

How does the lack of diverse female representation affect not just efficacy data, but side effect profiles and dosing recommendations?

Women differ in muscle mass, fat distribution, water content, and hormone levels — all of which affect how drugs are absorbed and processed. When trials don’t account for this, data becomes skewed. Side effects may be underreported or misattributed, and dosing guidance becomes less precise, especially for women at different life stages such as pregnancy or perimenopause.

Are decentralized trials and digital platforms helping close the gender gap in research participation?

Yes — virtual visits, remote participation, and at-home sampling can ease the logistical and caregiving burdens that often fall on women. Digital tools make it easier for women to take part in trials, particularly those juggling multiple roles or living far from clinical sites. This flexibility is an important step toward inclusive research.

Has FemTech moved the needle on more inclusive research, or are we still scratching the surface?

FemTech has empowered women to track their cycles, symptoms, and health data — which improves self-awareness and engagement. This can support more nuanced research. However, we’re still in the early stages of integrating this data into formal clinical protocols and healthcare systems.

How can trial designers better incorporate female-specific endpoints, especially for diseases that disproportionately affect women?

Women shouldn’t be treated as a “special population.” Instead, trial design must centre them by collecting data on menstrual cycles, contraceptive use, menopausal status and hormone levels. We need validated tools to measure female-specific symptoms — even if it adds complexity. Without this, insights will remain incomplete.

“We need validated tools to measure female-specific symptoms — even if it adds complexity.”

What regulatory or ethical changes would you like to see from agencies like the FDA, EMA, or MHRA?

Regulators should mandate sex-disaggregated data and incentivise inclusive recruitment — with financial benefits or faster review processes. Current policies often just require that sponsors show they “tried” to recruit women. That’s not enough. Proportional representation and meaningful analysis should be the baseline.

Are existing diversity guidelines being meaningfully enforced?

Some progress has been made, but the bar remains low. Often, showing an effort toward diversity is enough — regardless of the outcome. That said, enforcement must be balanced with ethical principles. Participation should always remain voluntary, and we must avoid overburdening trial teams working in good faith.

Would shifting to a value-based care model help accelerate inclusion of underrepresented populations?

Potentially. Value-based care rewards better outcomes, which could incentivise broader inclusion. But it also risks penalising providers for external factors like cultural or socioeconomic barriers. For the model to succeed, those challenges must be recognised and adjusted for — not ignored.

As a GP and medical monitor, what operational barriers prevent more women — especially from diverse backgrounds — from taking part in trials?

Many women are primary caregivers and face time and resource constraints that make participation difficult. This caregiving burden is a major systemic barrier to inclusion. Unless these hurdles are addressed, we’ll continue to see research gaps that affect the quality of care women receive.

What role can primary care providers play in improving recruitment of women into trials?

Time is a challenge — GPs often don’t have long enough consultations to explain research opportunities in detail. But even brief interactions can be powerful. Raising awareness and pointing patients to relevant trials during regular visits can make a big difference.

How do we balance inclusive recruitment with trial quality and protocol adherence, especially in decentralized or hybrid models?

Digital tools — like automated reminders — can support adherence, but human oversight is still essential. Study teams should proactively identify and support participants facing challenges, and adapt protocols where possible, such as accommodating disabilities or varying schedules. A balance of automation and personalised care is key.

What would a truly gender-inclusive clinical trial ecosystem look like — and how close are we to achieving it?

It would embed women’s health considerations at every stage: study design, recruitment, data analysis, and post-market review. This means treating inclusion as standard — not a checkbox.

Barriers to women’s health trials must be removed while maintaining scientific rigour. Protocols should reflect biological and experiential differences, and transparency about trade-offs is essential to build trust.

“Barriers to women’s health trials must be removed while maintaining scientific rigour.”

AI could be a powerful enabler — uncovering bias, refining recruitment, and delivering more precise outcomes. With sustained effort, meaningful progress is possible within five years.

Importantly, inclusion isn’t just about women. Equity-driven research will benefit everyone — from prostate cancer to cardiovascular risk in men. Real change requires collective action across regulators, researchers, funders and providers. But if we commit now, we can build a research ecosystem where equity is the default — not the exception.

Finally, what’s one thing every sponsor, CRO, or trial site could do today to improve representation in their research?

Recruit with intention. Strive for balanced gender representation in studies, and go beyond collecting data — analyse it by sex, age, ethnicity, and comorbidity to understand real-world impact. Representation isn’t just about fairness — it’s about better science.