Objective:

To examine the impact of decentralized clinical trials on participant diversity and access, highlighting specific inequities such as underrepresentation of minority groups.

Key Findings:

• Fewer than 3.5% of participants in the RESOLVE trial self-identified as Hispanic, indicating significant underrepresentation and raising concerns about trial inclusivity.
• Decentralized trials may trade one set of barriers for another, as they require reliable internet and digital fluency, which are not universally accessible.
• Remote trials can skew participant demographics towards younger, more educated, and digitally connected individuals, potentially limiting generalizability.
• Hybrid trial models can improve representation by combining in-person recruitment with remote follow-up, as evidenced by the CASCADE trial.

Interpretation:

Decentralized trials have the potential to enhance access but may inadvertently create new forms of exclusion, particularly for underrepresented populations, necessitating a focus on equitable design.

Limitations:

• Many remote outcome measures remain unvalidated against traditional in-person assessments, such as those used in the RESOLVE trial.
• Participation burdens have shifted to participants, who must manage technology and troubleshoot issues independently, which can disproportionately affect certain demographics.

Conclusion:

As remote trials become more prevalent, ensuring diverse representation should be a primary design consideration, with hybrid models being a viable solution to mitigate exclusion.