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.
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