Clinical Scorecard: Decentralized Trials Expand Access—but Risk Inequity
At a Glance
| 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 |
Key Highlights
- 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.
Guideline-Based Recommendations
Diagnosis
- Recognize that remote trial participation may skew towards younger, more educated, and digitally connected populations.
Management
- 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.
Monitoring & Follow-up
- 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.
Risks
- 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.
Patient & Prescribing Data
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.
Clinical Best Practices
- 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.
References
- Huang AJ, Marcus GM, Chan A-W. Decentralized Trials and Equity. JAMA. April 15, 2026.
- JAMA+ Trials Editorial Launch. JAMA.
This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.
