Decentralized clinical trials offer increased convenience and access, especially for rural or mobility-limited patients, but they risk excluding populations with lower digital literacy and access. Recent trials reveal underrepresentation of minority groups and challenges in remote participation, highlighting the need for hybrid designs to ensure equitable enrollment.
Background
Randomized clinical trials remain the foundation of evidence-based medicine, yet the methods of conducting them are evolving with technology. Decentralized trials leverage wearables, smartphone apps, and remote data collection to facilitate participation outside traditional research sites. While these approaches can reduce geographic and logistical barriers, they introduce new challenges related to digital access, participant burden, and validation of remote outcome measures. The rapid expansion of decentralized trials during and after the COVID-19 pandemic has outpaced thorough validation and raised concerns about representativeness and equity.
Data Highlights
Trial
Key Finding
RESOLVE
Fewer than 3.5% Hispanic participants despite higher disease prevalence
AMALFI
15% non-use rate for mailed ECG patches
PRACTICAL
Higher-than-expected non-initiation rates
CASCADE
~40% participants from racial and ethnic minority groups using hybrid model
Key Findings
Decentralized trials reduce physical site barriers but introduce digital access and literacy challenges.
Underrepresentation of Hispanic participants in the RESOLVE trial highlights inequity risks.
Remote participation burdens shift to managing technology and specimen collection without direct oversight.
Many remote outcome measures lack formal validation against in-person assessments.
Infrastructure optimized for convenience may disadvantage populations with the highest disease burden.
Clinical Implications
Clinicians should recognize that decentralized trials may not fully represent all patient populations, particularly those with limited digital access or fluency. Trial designers and institutional review boards should prioritize representativeness when adopting remote-first models, considering hybrid approaches to mitigate exclusion risks. Awareness of these limitations is essential when interpreting trial results and applying them to diverse clinical populations.
Conclusion
While decentralized trials expand access and convenience, they risk perpetuating or creating new inequities in participant representation. Thoughtful design incorporating hybrid models and validation of remote measures is critical to ensure trials remain inclusive and their findings generalizable.
