What happens when we design clinical trials with women in mind?
When only 22% of clinical trial participants are women (and even less are people of color), it means that most of the medicines on the market were never rigorously tested on the people who use them every day. It is no coincidence that women then experience significantly more adverse drug events than men; this is what happens when an entire sex is treated as an afterthought in the research and develop (R&D) process for bringing new drugs to market.
Some time ago, I had the opportunity to attend a webinar with Meri Beckwith from Lindus Health, and Valentina Milanova, the founder of a company called Daye that was preparing for regulatory approval of a diagnostic tampon.
For those of you not familiar with clinical trials, it’s an incredibly time consuming and costly part of R&D. I spent 15 years in management consulting for the life sciences, and my teams did many operations, experience transformation, and technical enablement projects in this arena.
My knowledge and experience left me intrigued to understand how Lindus achieved such a rapid, successful outcome for Daye. What I learned in their webinar was inspiring! They are explicitly focused on women’s health, and they treat the inclusion of women as a conscious design choice. Their work is clearly human-centered; they design the entire trial model around women’s real lives, needs, and risks so that female participation is both higher and easier to achieve.
Core philosophy: women aren’t “small men”
Lindus explicitly rejects the historical perspective that women can be treated as smaller male bodies in research. They recognize that physiological differences affect how women experience illness and respond to treatment, which means study design and safety monitoring must be sex‑specific from the outset. We need adequate female data before drugs and devices reach the market.
Trial design around women’s daily realities
From the outset, Lindus considers how the study will fit into participants’ actual routines, especially for mothers who face severe time and childcare constraints. They educate sponsors about adding stipends (for example, childcare support) to improve recruitment and adherence. Over time, Lindus has learned that these incremental operating costs are often offset by much faster enrollment and fewer delays – which are extremely expensive for sponsors. For the Daye diagnostic tampon trial, this philosophy translated into a fully at‑home sampling process that minimized time, discomfort, and clinic visits.
Patient‑centric operations that lower barriers
To make trials truly accessible to women, Lindus considers logistics, communication, and compensation at the outset, for example:
- Remote, flexible, and virtual options. Combined with home kits, fewer site visits, and digital touchpoints, this removes many time, travel, and childcare barriers.
- Accessible language. It’s an industry best practice to provide healthcare content at a reading level below the sixth grade. Lindus complements text with video and illustrated instructions, so women with different learning styles can give true informed consent and follow complex protocols.
- Multi‑language, multimodal content. They offer video, visuals, and simple copy to overcome language barriers and build trust with diverse patient groups.
- Compensation. The compensation is clearly explained up front, and recognizes the real costs women incur when they participate (e.g. childcare, transportation).
These are framed not as “nice to have” features, but as essential infrastructure for representative, high‑integrity data.
Digital‑first, data‑driven recruitment
Lindus treats recruitment as an iterative, data‑driven process designed backward from the target female population. Their team runs centralized digital campaigns and ties them to real‑time feedback, then quickly adjusts messaging and channels to close gaps in representation. They also
- Collaborate with women’s health organizations and communities focused on pregnancy, fertility, and gynecologic conditions, to reach women who are often under‑recruited into research.
- Use electronic health records and referrals from non‑trial sites to pre‑screen and route eligible women into studies without overburdening clinics.
In the Daye trial, this digital‑first, women‑centered recruitment allowed them to recruit the full cohort in under two weeks, an outcome the sponsor described as “record‑breaking.” In my experience, two weeks is an absolutely extraordinary outcome.
Guardrails for safety, trust, and long‑term impact
Perhaps the most compelling thing about how Lindus works is that they identify the risks to women’s participation, and mitigate them from the outset – rather than using risks as a reason to exclude women. They also push sponsors to include exploratory endpoints that capture “felt” outcomes and lived experience, arguing that trials in women’s health must measure what women actually care about, not just legacy clinical endpoints.
Lindus makes it look so straightforward, but there are hundreds of Clinical Research Organizations (CROs) today, and most of them are doing what they have always done. Which, of course, delivers the same imbalanced outcomes. It is only through the efforts of companies like Lindus that we’ll achieve the kind of long-overdue transformation we need in clinical trials to truly change the way we innovate and deliver care to women in the future.
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