The $200B Blind Spot: Why Women Still Don’t Exist in Most Clinical Trials - and How We Change That
A paradox worth billions
In 2024, the twenty best-selling drugs in the United States generated more than $200 billion in revenue. They save lives, extend hope and yet, 7 out of 10 of their pivotal clinical trials failed to represent women in line with the actual disease burden in the population.
Let that sink in: We are prescribing medicines to millions of women that were tested mostly on men or, in the case of some obesity drugs, disproportionately on women, without balance or nuance.
This isn’t a feminist talking point. It’s a scientific flaw and a commercial risk hiding in plain sight.
What the data shows
We reviewed FDA clinical-trial files, pivotal publications, and Drug Trials Snapshots for the Top 20 best-selling drugs in the U.S.
The findings are both simple and staggering:
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Overall: ~70 % of the top-selling therapies are not representative of women within a ±10 percentage-point band.
That means most of what we “know” about these drugs is derived from populations that do not reflect the real patients using them.
Why it matters
Safety: Women experience side effects 50–75 % more often than men.
Efficacy: Dosage, absorption, and hormonal cycles alter pharmacodynamics.
Equity: Women are the majority of healthcare consumers and the default caregiver, yet remain an afterthought in evidence hierarchies.
When women aren’t represented, everyone loses: regulators, payers, brands, and patients.
From awareness to accountability
Representation shouldn’t be a press-release promise; it should be a design variable.
Redefine “rigor.” A rigorous study is one that reflects the real-world gender distribution of disease.
Mandate visibility. FDA and EMA should require every new trial to publish its sex-split table — not in appendices, but in the abstract.
Tie funding to fairness. Public and private research grants should be contingent on representative recruitment plans.
Leverage AI for oversight. Machine-learning tools can monitor ongoing enrollment in real time and flag gender skew before it becomes statistical bias.
Demand it as leaders. Brand, strategy, and medical executives can make “Who did we study?” a standard slide in every deck — the same way we track ROI.
The leadership call
Women’s empowerment in healthcare isn’t only about more female CEOs or awards at conferences. It’s about data sovereignty, owning the numbers that shape our bodies, our biology, and our trust.
We don’t need pink campaigns. We need protocols designed for the full spectrum of womanhood: hormonal, racial, age-based, lived.
If science is the foundation of medicine, representation is the foundation of truth.
A generational opportunity
We stand on the verge of an AI-driven era that could finally see us. If we feed it biased data, it will amplify bias. If we feed it inclusive data, it can help regenerate equity at scale.
Let’s make this decade the one where every label, every dataset, and every clinical insight finally says: “Women were here.”
