Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups

Abstract

BACKGROUND: The importance of more diversity of study populations in clinical trials is currently widely acknowledged. Decentralized clinical trial (DCT) approaches are presented as a potential means to broaden diversity by eliminating several barriers to participation. However, the precise meaning of, and objectives related to diversity in DCTs remain unclear. Diversity runs the risk of becoming a 'buzzword': widely acknowledged to be important, yet prone to multiple interpretations and challenging to implement in practice. We argue that the aim of increasing diversity in clinical trials requires clear and well-substantiated specifications. METHODS: We analyze the concept of diversity and the ethical requirements surrounding fair participant selection within the context of clinical research, in order to further specify and operationalize the aim of increasing diversity in the context of DCTs. RESULTS: Through analyzing the concept of diversity and ethical requirements for fair participant selection, we propose that diversity should be specified in a way that improves the position of the groups that are currently most underrepresented in the research context. In practice, this entails that, in order to contribute to diversity, the selection of participants should prioritize (i) gaining scientific knowledge on groups for which this is lacking, and (ii) inclusion of underrepresented groups in research when appropriate considering a study's objectives, and risks and benefits. CONCLUSIONS: Our analysis facilitates translating the aim of increasing diversity with DCTs to more specific and actionable objectives for recruitment and inclusion. Moreover, it contributes to a further specification of the concept of diversity and fair participant selection in research contexts.