Sanskriti Thakur of decentralised clinical trial platform provider Medable, writing in the May 2023 edition of DIA’s Global Forum magazine, argues for an urgent rethink of clinical research to better include a more diverse patient population and protect women, mothers, families, and society at large.
This Mother’s Day, women across the US and in other parts of the world will be celebrated, but this appreciation is not reflected in scientific research, where women continue to face stark inequities. Today’s approach, investment, and mindset fail to deliver complete healthcare to women and limit data capture. Ultimately, this severely curtails the world’s understanding of disease states that impact women the most.
In the case of representation in clinical research, women are fighting for equitable consideration. In fact, compared to men, researchers know much less about how women experience disease, which is shocking because women represent half the global population. Gaps span from healthcare diagnosing (data generation) to tracking at the national level (data collection) and translating data into insights through epidemiological studies (data analysis). These data disparities ultimately influence health outcomes for women globally by creating blind spots in the insights that drive research design, investment decisions, and pipeline priorities. Without this baseline data, pharmaceutical companies are developing medicines that are inherently less safe and effective for women. In fact, a top reason for Food and Drug Administration (FDA) drug recall is adverse effects on women. These disparities in drug development threaten not only women’s health, but also the long-term welfare of families and communities.
Progress is being made: measures such as the proposed DIVERSE Trials Act are helping to shine a light on the need for fair and equitable representation in clinical trials. However, we have a long way to go to reach equity. To protect women, mothers, families, and society at large, we must act urgently to rethink clinical research.
Inequitable Representation Produces Suboptimal Treatments
Some diseases are more prevalent among women yet are often investigated in participant pools that do not represent this real-world dynamic. A recent study found asymmetry in cardiovascular disease research between men and women: 49% of people with cardiovascular disease are women, yet only 41.9% of participants in cardiovascular research are female. Additionally, heart disease is underdiagnosed in women, despite being the leading cause of death in the US.
The same study found similar research gaps for cancer: Although 51% of cancer patients are female, only 41% of cancer trial patients are female. Worse, 60% of people with psychiatric disorders are women, but just 42% of trial participants for psychiatric drugs are female.
These imbalances have real-world implications. Without equitable representation in trials, the management of care is suboptimal, and may result in debilitating side effects and missed signals about the safety and effectiveness of therapies. Women often process drugs differently than men. They can also experience different side effects than men, and experience those side effects at higher rates and/or to a stronger degree. And diseases often present differently in women than in men to begin with—which can turn fatal when those symptoms are understudied and therefore poorly understood. For example, heart disease—the leading cause of death for both men and women in the US—often develops in women a decade later than men due to protective effects of female hormones. Heart attack symptoms in women can also differ from those of men, presenting with extreme fatigue, indigestion, and chest or neck pain. Men, on the other hand, do not have those same symptoms. Another example is sexually transmitted infections, which can affect women differently in several ways, including the expression of symptoms and potential for long-term complications.