Diversity and ePROs: Still siloed concepts in the era of DCTs?

The type or format of an ePRO also matters as the preference may depend on the participant’s academic background. A study in 2020 showed that there was variability in preference for mobile-based versus website-based methods of ePROs amongst Black and white populations of those with cancer. A small number of Black participants preferred paper methods as they felt there was more time to think about the question, while some found it difficult to understand the paper symptom summary report.

Natalia Husby, solutions manager at CRO Curavit, explains that academic education may play a role in the difficulties experienced with interpreting the summary report. “This finding also highlights the importance of creating study materials that are accessible to people of varied academic backgrounds,” she adds.

When developing and tailoring questions for ePROs, sponsors and vendors should interact with patient communities to understand their experiences. “If it’s not relevant or salient to them, it’s going to be more difficult to recruit and retain,” Husby says. Indeed, improvement in quality of life could mean completely different things across various populations and regions, Mowlem adds.

If sponsors or vendors do not combine their ePROs with user experience, the technical brilliance of a product will not matter. Daniels explains that to improve the understanding of participant diversity, it is important to include patients in the protocol writing or run simulation studies to see if certain populations struggle with some of the questions in the ePRO. “If you can have technology that can adapt to different communities, that is where the culture and the product come together,” she says.

Decentralisation and all its methodologies have many features that could improve diversity in clinical trials, but now it is time to show the evidence for it, Mowlem says. Indeed, the data analysis shows that globally, only 27% of DCTs report data on race and ethnicity. “If we don’t report it, we can’t show that we’re improving diversity,” she adds.

The situation is better in the US, with 45% of US-based DCTs reporting diversity data. Yet, Mowlem says this is still quite low. The higher reporting proportion in the US compared to global DCTs may be attributed to the FDA’s effort to increase diversity. However, other regions are not at the same level as the US agency. While the European Medicines Agency (EMA) has a recommendations paper on DCTs,