Can we make clinical trials more diverse?

The US FDA are hoping to lead the way in addressing the lack of diversity and representation in clinical trials when developing medicines through new legislation. 

It has been widely recognised that there is a lack of diversity in clinical trials, something that is key to ensuring the medicine on trial is tested comprehensively, to make sure that it is effective in different patient populations. Even though this was known, there hasn’t been any regulation to mitigate the problem and ensure diversity in trials. 

Now, since a report from the US National Academies of Sciences, Engineering and Medicine was published in 2022 on building research equity for women and underrepresented groups, a shift in legislation has been encouraged. The report found that there was a significant lack of representation in clinical trials across North America, which gave rise to a number of consequences. 

These include incurring an extra cost of potentially hundreds of billions of dollars across the healthcare industry, curbs innovation and new discoveries, exacerbates the lack of accessibility to effective medicines, and leads to a lack of trust from patients in the medical establishment, among others. 

This isn’t to say there hasn‘t been an improvement in recent years, between 2012 and 2017 79% of clinical trials in the US used in decision making by the FDA achieved a good level of representation for women; however, this statistic is marred by the fact that 27% of trials adequately represented older adults, and even more disheartening, only 11% achieved a reasonable threshold for participants of minority racial and ethnic origin. This also highlights that the statistic for women largely implies the inclusion of women of white decent. 

To fulfil the new guidelines, researchers and pharmaceutical companies designing clinical trials will have to submit a plan for how they intend to incorporate more diverse participation in their trial. This will mean that these parties have to address structural and systemic problems that are the root cause of the current lack of diversity. Of course this can only mean progress, by making medical provision and trial sites more accessible and by working to build trust in these under-represented communities, which have so often been mistreated in the past. 

Jennifer Miller, a bioethicist at Yale School of Medicine (CT, USA), stated: 

“This is the first time we’re going to have companies proactively plan enrolment targets and submit them to regulators.”

Enforcing the regulations won’t be without it’s challenges, but it is a significant step towards rectifying the disparities in clinical trial recruitment and developing better medicines, and will hopefully inspire other regulators in different countries to put in place similar measures.