# Advancing Health Equity Through Linguistic Inclusion in Clinical Trials

> **NIH FDA U01** · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · 2024 · $250,000

## Abstract

Project Summary/Abstract
The proposed effort is focused on integrating community voices into existing organizational efforts to advance
linguistic inclusion in clinical research. Census data indicate that close to 1 in 5 people in the United States
(US) speak a language other than English at home. This number is significantly higher in urban areas, but rural
areas and midsized communities are also seeing a growing increase in the number of people who speak
languages other than English. Despite the growth in linguistic diversity in the US, linguistic diversity in clinical
trial and research participation overall remains limited. Linguistic inclusion is paramount to bringing more
treatments to all people more quickly. Inclusive samples reduce the ever-present bias towards English-
speaking individuals that inhibits generalizability to the broader population; whilst failure to include, fuels
homogeneity in trial participation and further stymies translation. Through our work with the Boston University
Clinical Translational Science Institute we have launched efforts to advance organizational changes to support
linguistic inclusion. This study builds on those efforts and is specifically designed to increase participation
Spanish-speaking patient participation in the design of our linguistic inclusion efforts. Through participatory
planning, we will engage patients with staff and researcher champions in the development of patient-informed
culturally and linguistically appropriate outreach and educational materials and researcher education.
Participatory planning can facilitate engagement and ensure that services reflect the needs of those on the
receiving end. As such, our specific aims are threefold. We will 1) Explore Spanish-speaking patients’
perspectives, preferences, unmet needs when considering joining clinical trials, and barriers to participation; 2)
employ a participatory planning process to design a) a messaging for a campaign focused on clinical trials
participation for Spanish-speaking patients; b) a patient-informed educational manual; and c) a “From Their
Voices” video for investigators that will be available in the IRB website; and 3) disseminate campaign
messaging and educational manual and video among Spanish-speaking patients, BUMC researchers and
more broadly. Solutions that lead to diverse linguistic representation among research participants are critical
for identifying and increasing access to specialized novel treatments that are effective for diverse racial, ethnic,
and cultural groups, and may, thus, serve to help reduce health disparities.

## Key facts

- **NIH application ID:** 11046024
- **Project number:** 1U01FD008264-01
- **Recipient organization:** UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
- **Principal Investigator:** Luis R. Alvarez-Hernandez
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2024-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11046024

## Citation

> US National Institutes of Health, RePORTER application 11046024, Advancing Health Equity Through Linguistic Inclusion in Clinical Trials (1U01FD008264-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11046024. Licensed CC0.

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