Decentralized Trials Expand Access—but Risk Inequity

Remote clinical research is proliferating fast. The field is still working out who gets left behind.

Category	Detail
Condition	Clinical trial participation and access
Key Mechanisms	Remote trial designs using digital platforms, wearables, and smartphone apps to collect data and facilitate participation
Target Population	Patients with various conditions, including chronic pain, across diverse demographic groups
Care Setting	Decentralized (remote) clinical trial settings, including hybrid models combining in-person and remote participation

Decentralized trials increase feasibility for rural, mobility-limited, and caregiving patients but require digital fluency and reliable internet.
Remote trials risk excluding populations with lower digital access, such as older adults, lower socioeconomic groups, and some ethnic minorities.
Hybrid trial designs combining in-person recruitment with remote follow-up improve minority representation and may mitigate exclusion risks.

Recognize that remote trial participation may skew towards younger, more educated, and digitally connected populations.

Incorporate hybrid trial designs to balance convenience with inclusivity, especially where digital access barriers are known.
Design remote trials with representativeness as a primary constraint rather than an afterthought.

Validate remote outcome measures against in-person assessments to ensure data reliability.
Monitor participant engagement and non-initiation or non-use rates of remote devices or interventions.

Potential for new or exacerbated inequities in trial participation due to digital access requirements.
Shifted participant burden to self-management of technology and specimen collection without direct oversight.

Participants in decentralized clinical trials, including underrepresented minorities and those with chronic conditions

Digital platform limitations and comfort affect participation rates; hybrid models may improve inclusivity and data generalizability.

Assess digital access and fluency barriers during trial design to avoid skewed participant populations.
Use hybrid recruitment and follow-up strategies to enhance diversity and representation.
Ensure remote outcome measures are validated against traditional in-person methods.
Provide support for participants managing technology and specimen collection remotely.