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Related Experiment Video

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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

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A Multiregional Decentralized Clinical Trial Program to Improve Access.

Tufia C Haddad¹, Lydia A Mercado², Jennifer G Le-Rademacher³

¹Department of Oncology, Mayo Clinic, Rochester, Minnesota.

JAMA Network Open

|June 5, 2026

Summary

Decentralized clinical trials (DCTs) increased participation from individuals over 120 miles from research sites. This suggests DCTs may improve access for underrepresented populations (URP) and rural residents.

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Area of Science:

Clinical Trials
Health Equity
Medical Research

Background:

Decentralized clinical trials (DCTs) aim to enhance trial accessibility for underrepresented populations (URP).
Ensuring diverse participant representation is crucial for study generalizability and policy relevance.

Purpose of the Study:

To evaluate trends in participant accrual from remote locations (over 120 miles from a research site) following DCT program implementation.
Assess the impact of DCTs on including participants from geographically distant, rural, and URP backgrounds.

Main Methods:

A descriptive quality improvement study was conducted at a US academic medical center (AMC) from January 2024 to March 2025.
DCTs were defined as trials with remote consent and other decentralized capabilities.
Participant data, including residential zip codes and demographics, were prospectively collected and analyzed quarterly.

Main Results:

The percentage of DCT participants residing over 120 miles from an AMC site increased from 18.9% in Q1 2024 to 29.6% in Q1 2025.
Accrual of participants from rural locations rose from 16.6% to 24.9% during the study period.
Representation of racial or ethnic URP also showed an upward trend, from 12.5% to 17.4%.

Conclusions:

DCT implementation showed favorable accrual trends among participants residing far from research sites, from rural areas, and from URP.
While not directly attributable to the program, these findings suggest DCTs may help overcome barriers to clinical trial access.
Further research is needed to confirm the sustained effectiveness and scalability of DCT models for improving trial equity.