Closing the Evidence Gap in Women’s Health: Lowering Barriers Now

Women’s health has been underfunded and under-researched for decades. Too many products reach the market without sex-specific data, while conditions that disproportionately affect women remain poorly studied. That’s beginning to change — but the field doesn’t just need more money, it needs easier, faster, and more structured ways to generate evidence.

Momentum Is Building

The tide is finally turning.

• In 2024, the Gates Foundation pledged $2.5 billion through 2030 for women’s health R&D — a signal that global health leaders now see the gap as urgent and addressable.
• In 2024, ARPA-H also launched a $100 million “Sprint for Women’s Health” to speed R&D in priority areas, the first major deliverable of the White House Initiative on Women’s Health Research
  
  

These commitments are overdue, but they highlight what innovators in this space already know: women’s health doesn’t just need more funding — it needs infrastructure that makes credible evidence generation possible for more researchers, more products, and more participants.

The Evidence Gap: What Needs to Change

1. Research must be sex-specific. Too often, studies lump women into “general populations” without analyzing outcomes separately. Whether you’re studying pain, sleep, mood, or metabolic health, women experience these outcomes differently — and trials must be designed to reflect that.
   
   
2. Endpoints must reflect women’s experiences. Many validated questionnaires in clinical research don’t capture the nuances of women’s health. Tools like the Menstrual Symptom Questionnaire, the Menopause Rating Scale, and endometriosis-specific PROMs are essential.
   
   
3. Wearables offer untapped potential. Menstrual cycle tracking, basal body temperature, and other wearable-derived signals are already being captured by millions of women. With the right infrastructure, these data can become meaningful endpoints in structured studies.
   
   
4. Recruitment must be representative. Women are underrepresented in many clinical trials — especially women of color, women with complex comorbidities, and women at different reproductive life stages. Decentralized recruitment can change that, but only if it’s intentional.
   
   

Alethios: Solving a Critical Problem

At Alethios, our mission isn’t just to lower the barriers for companies running studies. It’s to democratize who gets to participate in research and who gets to lead it.

That means:

• Expanding endpoints. We’re continuously adding validated women’s health–specific questionnaires, and enabling integrations for wearable endpoints like menstrual cycle tracking, sleep disruption during menopause, and basal temperature monitoring.
  
  
• Recruiting the right populations. Through our growing Alethiad participant database, we can rapidly recruit women with lived experiences that matter to research — from disease states like endometriosis to life stages like menopause.
  
  
• Making participation easier. By designing participant-friendly, at-home studies, Alethios reduces the friction that often keeps women out of research: travel burden, caregiving responsibilities, and time constraints.
• Opening the door to more women as researchers. Alethios makes it affordable and feasible for women founders, clinicians, and innovators to run credible studies without needing a CRO-sized budget.
  
  

The result is a research infrastructure purpose-built to close the evidence gap: faster studies, more meaningful endpoints, and more representative participants.

Customer Spotlight: Samphire Neuroscience

Samphire Neuroscience is developing a non-invasive neuromodulation device for menstrual-related symptoms. They represent the kind of innovation that needs accessible evidence generation: device-based, participant-friendly, and designed for at-home use (TechCrunch coverage). With Alethios, they can rapidly design structured studies that capture outcomes like pain reduction, mood, and daily functioning — all without the cost or friction of a traditional site-based trial.

Why Lowering Barriers Matters

• For innovators: Credible, sex-specific data drives partnerships, regulatory alignment, and investor confidence.
  
  
• For funders: Billions in new grants and venture capital will only create impact if innovators can actually afford to generate credible results.
  
  
• For participants: Women deserve products built on evidence that reflects their bodies and experiences.
  
  

Where Alethios Fits

Alethios is research infrastructure built to be HIPAA-compliant. We make it possible to design, run, and report on credible women’s health studies in weeks, not years. Whether that means analyzing an existing dataset for sex-specific signals, running a brand-new observational or randomized study, or layering in women’s health–specific endpoints, Alethios makes it possible.

By lowering the cost and complexity of evidence generation, we turn “it’s too hard” into “it’s doable.” And by democratizing both participation and research leadership, we help ensure that the next decade of women’s health innovation isn’t just better funded — it’s better designed.

Final Take

Closing the evidence gap in women’s health isn’t optional — it’s essential. The funding is here. The urgency is clear. What’s needed now is the infrastructure to turn intent into credible results. Lowering the barriers to evidence generation is how we get there.

References & Further Reading

1. Gates Foundation to commit $2.5 billion to women’s health over the next 10 years — Reuters
   
   
2. Advanced Research Projects Agency for Health. “ARPA-H Announces Sprint for Women’s Health.” 21 Feb. 2024
   
   
3. AP News coverage of Gates Foundation women’s health funding
   
   
4. Samphire Neuroscience — Company site
   
   
5. Samphire Neuroscience raises funding to expand women’s health neuromodulation — TechCrunch
   
   
6. FDA Guidance on Diversity Plans to Improve Enrollment in Clinical Trials

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