Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Apr 24;26(1):51.
doi: 10.1186/s12910-025-01211-7.

Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups

Tessa I van Rijssel  1   2 , Johannes J M van Delden  3 , Bart Lagerwaard  3 , Mira G P Zuidgeest  3 , Ghislaine J M W van Thiel  3 ; Trials@Home consortium
Affiliations
Review

Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups

Tessa I van Rijssel et al. BMC Med Ethics. .

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.

Keywords: DCTs; Decentralized clinical trials; Diversity; Fair participant selection; Research ethics.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

References

    1. Flores LE, Frontera WR, Andrasik MP, Del Rio C, Mondriguez-Gonzalez A, Price SA, et al. Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Netw Open. 2021;4(2):e2037640. - PMC - PubMed
    1. Kennedy-Martin T, Curtis S, Faries D, Robinson S, Johnston J. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials. 2015;16:495. - PMC - PubMed
    1. Duma N, Vera Aguilera J, Paludo J, Haddox CL, Gonzalez Velez M, Wang Y, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract. 2018;14(1):e1–10. - PubMed
    1. Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, et al. Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process. Trials. 2020;21(1):694. - PMC - PubMed
    1. Emanuel EJ, Grady C. Four paradigms of clinical research and research oversight. Camb Q Healthc Ethics. 2007;16(1):82–96. - PubMed

LinkOut - more resources