Liz Beatty

The lack of diversity in clinical trials is a disturbing, ethical problem that’s persisted for decades. It’s also an issue that creates significant community and global health risks, as diverse patient populations have different responses to certain diseases and pharmaceuticals.

Thankfully, the clinical trial sector is increasingly recognizing the severity and ramifications of its lack of diversity. Moderna and Pfizer's COVID-19 vaccine trials have repeatedly come under

 scrutiny for trial participants not adequately representing the general population and those most impacted by COVID-19, for instance. The FDA is also continuing to expand on its guidelines

 for enhancing the diversity of clinical trial populations.

Acknowledgement of a lack of diversity is an encouraging first step; however, it’s still unclear what’s actually being done to solve this problem. How are community clinical trial sites—or those outside of the typical large academic research centers—taking action to establish trust with prospective participants who’ve never before navigated the nuances of the clinical trial landscape? How are large, academic sites ensuring their own staff understand the language and culture of prospective participants? Perhaps most importantly, how are pharmaceutical sponsor organizations holding themselves accountable for meeting their diversity goals?

Based on data from my company’s global clinical trial marketplace,

 a crucial first step in overcoming a lack of diversity is looking inward and ensuring a healthy portion of your organization’s staff represents the desired demographic(s) of your trial participants. Seventy-five predominantly North American sites in our marketplace have gone a step further by using specific metrics to objectively measure and progress against their diversity goals. Examples of these metrics include:

Defining the characteristics of the local community and understanding their challenges

Having a hiring strategy for staff that mirrors that demographic of the community

Being linguistically similar to the community

Having a process to identify barriers to healthcare and study participation, and having measures to mitigate these barriers

Physically going into the community to recruit participants (i.e., building trusted community relationships)

Establishing and tracking against benchmarks like these can drive real results, as 77% of sites in our marketplace with high diversity “scores” have already experienced an increase in diverse patient enrollment and/or retention. Furthermore, 85% of sites in our marketplace that implemented such metrics reported they were better able to market themselves toward sponsors to meet their diversity goals.

Despite the concrete action many sites are taking to incite greater diversity—as well as their undeniably promising results thus far—data from our global clinical trial marketplace shows that sponsors are continuing to underutilize diverse sites. While 61.5% of sites in our marketplace said sponsors are being more specific about their diversity goals as compared to 1-2 years ago, only 57% of sites said sponsors were contacting them to support diversity enrollment in trials. What’s more, 46% of sites reported that sponsors still weren’t sharing their diversity goals or targets for recent or upcoming trials.

Building and maintaining greater diversity in clinical trials is certainly an overwhelming and at times paralyzing task. And it can be even more challenging when speed is a factor, as we’ve witnessed with the trials for COVID-19 vaccines. However tangible action is required, and now. Establishing and tracking against diversity-related benchmarks is a great starting point, as is assigning specific diversity goals to certain trials.

Ultimately, given the power sponsors hold in promoting greater diversity across the entire clinical trial sector, the onus is on them to step up. It’s time to stop talking the talk and start walking the walk by seeking out new, additional sites to partner with that have proven diversity traction and success. In doing so, sponsors have an opportunity to significantly lower their trial costs and get treatments to market faster—all while ensuring different demographics and those who face the most risk of the disease in question are accurately and fairly represented.

https://www.fastcompany.com/90555722/why-covid-19-vaccine-trials-still-need-more-diversity

https://www.fda.gov/media/127712/download

https://inato.com/blog/the-marketplace-diversity-assessment-improving-diversity-in-clinical-trials/

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Liz Beatty

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Clinical Trial Diversity: It’s Time to Stop Talking the Talk and Start Walking the Walk