Modern medicine often treats male biology as the standard. This leaves women at risk of misdiagnosis and dangerous side effects. Now, a Swedish startup is dismantling this systemic failure. TrialMe is rebuilding medical research to finally include half the world’s population.
The Personal Cost of Missing Data
The gender health gap is not just a statistical error. It has real human consequences. Hanna Kalesse, a medicinal chemist, understood this theoretically during her studies. Then she experienced it firsthand.
Doctors prescribed Kalesse a medication they said would require a two-week adjustment period. They told her she could continue working and studying as normal.
The reality was drastically different.
“It completely knocked me out for nine months,” Kalesse revealed.
She could not ride a bike. Reading became impossible. Even holding a conversation was a struggle. The drug turned her life upside down because the dosing guidelines did not account for her specific biology.
This adverse reaction sparked an idea.
Kalesse teamed up with a friend for a women’s health hackathon at Sahlgrenska Science Park. They placed in the top three. With encouragement from Daya Ventures, they turned their concept into TrialMe.
smartphone app screen displaying clinical trial match for women
Why Women Are Left Behind in Science
The medical community has historically excluded women from clinical trials.
Researchers viewed female hormonal cycles as variables that made data “too complex” to analyze. They also feared potential risks to fertility or pregnancy.
Consequently, we have decades of medical data based largely on male physiology.
This creates a dangerous blind spot for conditions that disproportionately affect women.
- Autoimmune diseases
- Migraines
- Chronic pain
- Alzheimer’s disease
- Cardiovascular issues
Doctors often treat these conditions without sex-stratified clinical data.
This leads to higher rates of misdiagnosis. Women also suffer from adverse drug reactions nearly twice as often as men.
Regulatory bodies are finally catching up.
The United States mandated the inclusion of women in NIH-sponsored research in 1993. However, Europe lagged behind significantly.
The EU Clinical Trials Regulation was only amended in 2022. It now requires trial populations to reflect the demographics of the people who will actually use the drug. Sponsors must now justify any lack of gender balance.
The Gender Gap Reality
- Recruitment Cost: Sourcing patients accounts for 40% of a trial’s total budget.
- Failure Rate: Around 80% of clinical trials fail to recruit participants on time.
- Safety Risk: Women are routinely overmedicated because dosages are calculated for an average male body.
Tech Solution to a Biological Problem
TrialMe aims to solve the recruitment bottleneck while empowering women.
Recruitment is expensive and inefficient. Researchers waste budget on hundreds of phone calls just to find a handful of eligible people.
TrialMe digitizes this process.
The platform works directly with research organizations and trial sponsors. It offers a verified community of engaged women.
The app removes the friction that usually stops people from signing up.
Users do not have to browse endless listings. The app works like a matchmaker. It sends a notification only when a specific trial suits the user’s profile.
Kalesse emphasizes that women already carry a heavy cognitive load. Participating in research should not add to that burden.
The app filters out ineligible participants early.
This saves sponsors time and money. It ultimately helps bring safer drugs to market faster.
To build trust, Kalesse is testing the system from the inside. She is personally participating in a documented clinical trial to show women what the process looks like.
She found that finding a trial on her own was nearly impossible. Websites were outdated. Many contacts never replied.
That frustration became the core market research for the app.
The platform also rewards participation. Users can earn points for gym memberships or therapy sessions. They also gain early access to new women’s health products.
Improving Recruitment and Patient Safety
The startup is currently running pilot programs focused on menstrual cycles and medication interactions.
There is growing evidence that side effects correlate with different phases of a woman’s cycle.
Kalesse notes that antidepressants often have side effects linked to hormonal changes. In her own case, medication intensified her menstrual symptoms.
In an ideal future, doctors could prescribe phase-specific dosing.
This would mean adjusting medication amounts depending on where a patient is in her cycle.
TrialMe is not limited to pharmaceutical drugs.
The platform also facilitates testing for digital health tools and at-home diagnostics.
Innovations like at-home endometriosis tests need validation before they hit the mass market. These products often come from small companies that struggle to find testers.
The startup is beginning its journey in Sweden. However, the vision is global.
Minority groups are also systematically excluded from medical research. Kalesse intends to expand the model to address these disparities once the platform is perfected in smaller markets.
The company recently won a global pitch competition organized by Tesla Ventures. This victory secured them a mentorship program led by women in Ireland.
Clinical research requires healthy volunteers as well as those who are ill.
Every participant helps close the data gap. The team believes this is the only way to ensure medicine becomes safe for everyone, not just the “default” male patient.
TrialMe is proving that better data leads to better healthcare. By connecting women directly to researchers, they are ensuring the future of medicine is female-inclusive.
