TL;DR: How TrialMe is Revolutionizing Female Representation in Clinical Trials
TrialMe, a Swedish startup, addresses the historical underrepresentation of women in clinical trials by providing a transparent, user-friendly app for women to participate meaningfully in medical research.
• Matches women to appropriate trials via a "smart matching" system.
• Builds trust with transparent data usage and gamified rewards.
• Highlights the urgency of including women’s data for equitable healthcare outcomes.
Explore how your innovative ideas can address systemic biases like this. Visit TrialMe’s journey on Tech.eu for inspiration!
Through the decades, clinical research has suffered from a notorious blind spot: its failure to fully account for female biology. Historically, women, particularly those of reproductive age, were marginalized in clinical trials for reasons ranging from supposed hormonal complexities to concerns over fetal health. This has left a critical gap in data that impacts women’s healthcare outcomes to this day. Enter TrialMe, a Swedish startup founded by medicinal chemist Hanna Kalesse, aiming to revolutionize how women are represented in clinical research.
TrialMe’s solution is both simple and disruptive, it provides women with an accessible, transparent gateway to participate in clinical trials, ensuring their data significantly contributes to the medical research ecosystem. As an entrepreneur myself, deeply embedded in Europe’s startup and tech scene, I believe this is more than just a technological fix; it’s about rewriting decades of ingrained inequality in healthcare with focused, data-driven solutions. Let’s explore how TrialMe is solving this problem while reshaping perspectives on gender equity in clinical testing.
Why Have Women Been Left Out of Clinical Trials?
The scientific bias that excludes women from clinical testing has historical roots. Before 1993, when the NIH first mandated gender inclusion in government-funded U.S. trials, drug testing in the Western world predominantly revolved around male subjects. Europe legislatively addressed this much later, in 2022, with amendments to the EU Clinical Trials Regulation. Unfortunately, these changes have been slow to filter through, leaving a legacy of incomplete, male-biased medical research.
- Drug dosages are frequently calibrated based on male physiology, leading to higher rates of adverse drug reactions in women.
- Many life-altering conditions that disproportionately affect females, such as autoimmune diseases and chronic pain, remain under-researched due to this bias.
- Women of childbearing age are often excluded entirely due to concerns about unforeseen effects on pregnancy.
Such exclusions perpetuate the notion that male biology is the default, a harmful myth that TrialMe seeks to debunk by not only inviting women into the clinical trial space but making their participation meaningful.
What Is TrialMe’s Unique Approach?
Rather than taking a generalized approach to trial recruitment, TrialMe focuses on addressing the visibility gaps in women-centered data. At its core is a mobile app crafted to make trial participation intuitive and bias-free. Here’s how it works:
- Smart Matching: Using pre-set filters and questionnaires, the app matches users with trials that align with their health profiles, conditions, and symptoms.
- Robust Transparency: Women see exactly how their data will contribute to research outcomes, fostering trust and accountability.
- Incentivization: Trial participants earn rewards, like therapy discounts or wellness products, ensuring engagement while offsetting any challenges like time or logistical constraints.
- Education: Through integrated tutorials and a community platform, TrialMe empowers users to understand how data is analyzed and why their biology matters.
As an advocate for useable tech, I see TrialMe as an exemplar of how to eliminate entry barriers through thoughtful design. Beyond ensuring representation, these elements build much-needed trust in a system that has historically sidelined certain demographics.
Why Data Representation for Women Matters
Why should entrepreneurs and the broader public care about female representation in clinical trials? The answer lies in the real-world consequences that ripple far beyond healthcare into productivity, quality of life, and broader socio-economic factors. Consider the data:
- Women are nearly twice as likely as men to experience adverse drug reactions due to poorly calibrated dosages and side-effects.
- Heart attacks present differently in women than in men, leading to frequent underdiagnosis or misdiagnosis.
- Conditions like endometriosis and PCOS remain underexplored, affecting millions of women globally.
The absence of women’s data isn’t just a moral failure, it’s a financial and healthcare liability, reminiscent of the kind of blind spot that technologists and business founders like me are emboldened to address. Clear, inclusive data unlocks actionable insights for pharmaceutical companies, healthcare workers, and patients alike.
How Does TrialMe Build Trust?
Hanna Kalesse has flipped the script on the traditionally opaque world of clinical trials. Through her platform, she models the change she wants to see. By participating in clinical trials herself and sharing her journey transparently, she demonstrates authenticity and commitment to the cause. This simple leadership approach is already paving the way for wider adoption and trust-building among women.
The platform also incorporates a gamified rewards system. By acknowledging women’s contributions to science and incentivizing their time and effort, TrialMe taps into intrinsic and extrinsic motivators, a classic example of how gamification can work wonders beyond traditional tech education or productivity tools.
How Can Startups Play a Role in Addressing Systemic Bias?
Startups thrive by finding and fixing blind spots. It’s what set companies like TrialMe apart: leveraging technology and focusing on long-ignored or misunderstood problems to create scalable impact. This journey shows that tech isn’t just about efficiency or productivity, it can redefine norms by addressing underrepresented demographic needs.
- Broaden your founding team to include diverse perspectives.
- Design solutions that address underserved markets, whether it’s women, minorities, or otherwise overlooked groups.
- Ensure accountability by building transparency and equal representation into your offerings.
- Embed empathy and lived experience into product development; it’s not just smart, it’s good business.
If TrialMe teaches us anything, it’s that meaningful progress often starts with examining where we’ve failed in the past, and leaning into uncomfortable truths. For today’s entrepreneurs, the lesson is clear: inclusivity isn’t optional anymore; it’s central to both success and relevance.
As someone who knows firsthand the pitfalls and promise of innovation, I’m inspired by services like TrialMe that bridge the gap between lofty ideals and practical solutions. With its bold mix of technology, empathy, and education, TrialMe represents the beginning of a journey, one to level the playing field in perhaps the most important arena of all: our health.
If you’re a founder, or simply someone passionate about bringing transformative ideas to life, there are lessons to learn here. Rethink your approach to bias in the markets you target. Build your vision on foundations of equality and measurable impact because the best innovations don’t just solve problems, they revolutionize lives.
To understand more about creative, impactful entrepreneurship, explore platforms like TrialMe’s journey on Tech.eu and dive deep into how one startup is changing the future of healthcare as we know it.
FAQ on TrialMe and Women’s Data Representation in Clinical Trials
How does TrialMe help women participate in clinical trials?
TrialMe simplifies participation in clinical trials through its innovative mobile app platform. Using features like Smart Matching, intuitive pre-set filters align users with relevant trials based on their health profiles, symptoms, and conditions. The app also prioritizes transparency by clearly showing how participants’ data influences medical research outcomes. This trust-building approach encourages women to actively contribute to improving healthcare data representation. Additionally, the app includes incentivization methods, such as rewards like therapy discounts and wellness products, lowering barriers to engagement. Learn more about TrialMe’s contribution
Why were women traditionally excluded from clinical trials?
Historically, concerns over fetal health risks and the complexity of hormonal fluctuations led to excluding women, especially those of reproductive age, from clinical trials. Men's biology was seen as the “default,” sidelining crucial research into female-specific diseases and conditions. Even today, some regions implement restrictive policies, perpetuating the exclusion by citing recruitment challenges or risks. This systemic bias has resulted in years of poorly calibrated drug dosages affecting women disproportionately. Understand the historical challenges
What is the impact of gender bias in clinical trials on health outcomes?
The impact of gender exclusion is far-reaching, leading to inaccurate diagnostic protocols and adverse drug reactions for women. For example, medications and drug dosages often don’t account for female metabolic differences, while conditions like endometriosis and PCOS remain under-researched. Heart attacks in women frequently present differently than in men, leading to misdiagnosis. Addressing this bias through inclusive research can improve health outcomes and productivity. Read about gender bias consequences
How does TrialMe’s incentivization system work?
TrialMe’s app incorporates a gamified rewards system, providing participants with points they can redeem for therapy discounts, gym memberships, or women’s health products. This approach acknowledges participants’ contributions to science and offsets barriers to engagement, such as logistical constraints or time considerations. By making participation beneficial beyond just altruistic motives, TrialMe ensures higher retention rates and trust among users.
What are the regulatory changes related to gender inclusion in clinical trials?
In 1993, the NIH mandated gender inclusion in government-funded U.S. trials, addressing the exclusion of women. Europe followed much later, amending the EU Clinical Trials Regulation in 2022 to require demographic representation, including gender balance. However, sponsors can still cite recruitment difficulties or potential risks to justify exemptions, slowing down progress. Explore regulatory updates
What steps has TrialMe taken to ensure data transparency?
TrialMe actively builds trust by demonstrating the value of women’s contributions. Users see how their data drives meaningful insights in medical research through detailed tutorials and community engagement features. Founder Hanna Kalesse models transparency by participating in trials herself and documenting the experience for others. This openness eliminates historical mistrust in clinical research processes.
Why is female representation in clinical trials a priority?
Female representation ensures medicine is based on diverse physiological data, improving safety, efficacy, and diagnosis accuracy. For example, women are nearly twice as likely to experience adverse drug reactions due to male-centric dosing. By including women’s data, researchers can uncover cycle-specific disease patterns and align treatments with real-world patient profiles, advancing personalized medicine. Check out TrialMe’s impact on inclusivity
How does TrialMe match participants with trials?
TrialMe uses advanced filtering in its app, based on questionnaires detailing health conditions, symptoms, and profiles. Through “Smart Matching,” users are connected to trials that align with their needs and interests. This efficiency reduces recruitment delays while ensuring patients are matched accurately, saving time and resources for sponsors and participants alike.
How is TrialMe contributing to research gaps like endometriosis?
TrialMe supports pilot studies targeting under-researched conditions such as endometriosis, chronic pain, and PCOS. Through technology that standardizes data collection for diseases disproportionately affecting women, TrialMe addresses visibility gaps in medical research. Features like educational tutorials and community platforms empower participants to understand their pivotal role in solving these research gaps.
Can startups address systemic bias effectively?
Startups like TrialMe show how technology can create scalable solutions to address neglected demographics. Innovations like mobile app-based trial recruitment, incentivized contributions, and transparent data usage exemplify how startups can leverage empathy and inclusivity for societal and business impact. Founders are encouraged to embed diverse perspectives in their teams for creating real, impactful change. Explore how startups can drive change
About the Author
Violetta Bonenkamp, also known as MeanCEO, is an experienced startup founder with an impressive educational background including an MBA and four other higher education degrees. She has over 20 years of work experience across multiple countries, including 5 years as a solopreneur and serial entrepreneur. Throughout her startup experience she has applied for multiple startup grants at the EU level, in the Netherlands and Malta, and her startups received quite a few of those. She’s been living, studying and working in many countries around the globe and her extensive multicultural experience has influenced her immensely.
Violetta is a true multiple specialist who has built expertise in Linguistics, Education, Business Management, Blockchain, Entrepreneurship, Intellectual Property, Game Design, AI, SEO, Digital Marketing, cyber security and zero code automations. Her extensive educational journey includes a Master of Arts in Linguistics and Education, an Advanced Master in Linguistics from Belgium (2006-2007), an MBA from Blekinge Institute of Technology in Sweden (2006-2008), and an Erasmus Mundus joint program European Master of Higher Education from universities in Norway, Finland, and Portugal (2009).
She is the founder of Fe/male Switch, a startup game that encourages women to enter STEM fields, and also leads CADChain, and multiple other projects like the Directory of 1,000 Startup Cities with a proprietary MeanCEO Index that ranks cities for female entrepreneurs. Violetta created the “gamepreneurship” methodology, which forms the scientific basis of her startup game. She also builds a lot of SEO tools for startups. Her achievements include being named one of the top 100 women in Europe by EU Startups in 2022 and being nominated for Impact Person of the year at the Dutch Blockchain Week. She is an author with Sifted and a speaker at different Universities. Recently she published a book on Startup Idea Validation the right way: from zero to first customers and beyond, launched a Directory of 1,500+ websites for startups to list themselves in order to gain traction and build backlinks and is building MELA AI to help local restaurants in Malta get more visibility online.
For the past several years Violetta has been living between the Netherlands and Malta, while also regularly traveling to different destinations around the globe, usually due to her entrepreneurial activities. This has led her to start writing about different locations and amenities from the point of view of an entrepreneur. Here’s her recent article about the best hotels in Italy to work from.
