Women remain underrepresented in clinical trials, but a new women’s health-focused CRO aims to change that. In fact, more CROs are targeting specialized populations and diseases that have historically been less of a focus.
What “women’s health” typically implies are areas like sexual and reproductive health. But other conditions such as heart disease and high cholesterol are studied less often in women and are critical to women’s overall health. Dr. Charlotte Owens, head of medical affairs and outcomes research at Organon, argues that women’s health needs to be redefined altogether.
Some drugs also have different pharmacokinetics and side effect profiles in women and must be prescribed differently, like the insomnia drug zolpidem, sold under brand names like Ambien. The FDA changed the recommended starting dose and strengthened side effect warnings for women many years after it hit the market.
“We see increasing recognition that there is this huge research gap,” said Meri Beckwith, co-founder of Lindus Health, a clinical trials startup backed by billionaire Peter Thiel.
A newly launched CRO from Lindus Health is designed to address the need for a wider lens on drug development, managing all project-related activities for women’s health trials from start to finish.
A female focus
In addition to its expertise and experience on the clinical side of women’s health, Lindus’ new women’s health CRO will address the ethical and social factors that have historically kept women underrepresented in clinical trials.
Among them are concerns that an experimental drug could harm a pregnancy or fertility down the line.
“Something a CRO should absolutely do is make sure that female subjects are aware of those risks and true informed consent is given,” Beckwith said. “That’s something that, surprisingly, CROs are not great at.”
A CRO with women’s needs at its core can also help sponsors develop study protocols and recruitment and retention strategies that consider the social barriers and other stigma that limit women’s participation in clinical research. For instance, Beckwith said providing a modest child care stipend for participants with young children can help boost enrollment for new mothers.
“We see increasing recognition that there is this huge research gap."
Meri Beckwith
Co-founder, Lindus Health
Although some sponsors may worry that such an allowance might be perceived as coercion, Beckwith said.
“The downside of not having those people participate and then missing out on that data and potentially a very impactful treatment for an important condition massively outweighs the theoretical problems around coercion,” Beckwith said.
A trend in the making
Lindus isn’t the only CRO with a program focused on specific patient populations. Parexel offers specialization for rare diseases, pediatrics and cell and gene therapies. Syneos Health has a focus in women’s health and cell and gene therapy. And Medpace has CRO capabilities in women’s health and pediatrics, among other areas.
But there are many underserved patient populations that lack both specialized CROs and clinical trial representation — despite increased industry attention, diversity in clinical trials continues to suffer overall.
Research published last year showed that clinical trial participation among Black patients actually dropped between 2018 and 2022.
Elderly patients are also underrepresented. Although nearly 95% of people 65 and older have at least one chronic disease, clinical trial enrollment among older adults remains low. For instance, this age group makes up the highest percentage of cancer diagnoses and deaths but only about 30% of participants in oncology clinical trials.
Similar disparities exist across other underrepresented groups, including disabled, indigenous and transgender and nonbinary people.
Yet boosting clinical trial participation among underrepresented and underserved groups isn’t just good for patients. It also has the potential to be good for sponsors.
“Frankly, it's a market opportunity,” Beckwith said.
