On average, women are more than three times more likely than men to suffer from whiplash if their car is hit from behind. Across the board, women are more likely to suffer severe injuries than men in similar car accidents.
This makes sense. Crash test dummies used to design car safety are based on the average 1970s male — 175cm tall (5ft9) and 78kg (172lbs). It’s only - I kid you not - less than a year ago that the first female crash test dummy ever was taken into commission in a lab in the Swedish city of Linköping.
That bias persists beyond dummies. The lack of female representation in clinical studies is a big problem with consequences for women’s health. Men and women experience different symptoms and responses to treatments, as well as different disease trajectories. Failing to include a diverse range of participants in clinical studies means that certain groups, including women, may not receive the same level of care and attention. (The issue is even worse for women of color.)
Many women have horror stories about seeing multiple doctors before their symptoms were even taken seriously. After all, “it’s just stress/period issues/ menopause” is an easy cop-out for (mostly male) physicians. Most of these physicians are not ill-intentioned. In many cases, the knowledge simply isn’t there. It’s only in the last few decades that (aiming for) gender parity in clinical trials has become important.
The lack of female representation is a widespread issue that affects a range of medical conditions and treatments, with serious implications for women’s health. It means that the treatments and medications available to women may not be as effective as they could be, not to mention the lack of basic knowledge about how certain medical conditions affect women.
But how bad is it really?
A 2022 study investigated how underrepresented women are in clinical trials between 2016 and 2019 — 1,433 trials with 302,664 participants overall. They focused on the two main killers (cardiovascular disease and cancer) and mental health conditions (the world’s leading cause of disability!).
The scientists then compared the conditions’ prevalence in the general population with participation in clinical trials. This allows them to conclude whether or not women are actually underrepresented. For example, if there is a condition that affects men and women perfectly equally, ideally you want clinical trials where 50% of the participants are female and 50% are male. When the prevalence and the participation in trials match, you’ve got a good representation.
Here we go:
Cardiovascular disease: 49% of patients are women (prevalence); clinical trials include almost 42% women (participation) → women underrepresented.
Cancer: 51% of patients are female; 41% of clinical participants are → women underrepresented.
Mental health conditions: 60% of patients are women; only 42% of clinical trial participants are → women underrepresented.
While these numbers are already a great improvement in comparison to earlier studies, there’s clearly still some work to do. This will, of course, depend on the field of medicine. For example, one of the few areas in which men are underrepresented is that of preventative interventions. (An ego issue, perhaps?)
As a side note: prevalence data is based on diagnosed cases. In mental health, for example, we know that men are less likely to seek help because of the stigma of a mental health diagnosis.
As another side note: the authors focus on differences in biological sex. This does not perfectly mirror differences in gender identity and omits intersex people.
Here too, there is no ill intent by the researchers running the trials. Many of them are aware of the issue. There are many barriers that may prevent the equitable participation of women in clinical trials, from access and information to transportation or lack of proper incentives. And let’s not forget that, on average, women are still responsible for the majority of housework and caregiving. That makes it harder to free up time to participate in a trial.
The study concludes:
Further efforts are still needed to ensure that clinical trial populations align more closely with the demographics of the population affected by disease. Continued progress with regards to the representation of females in clinical trials is crucial to ensuring that the efficacy and safety of drugs and devices approved for use in the United States are tested appropriately for both sexes.
We need more women.
And not just in clinical trials…
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