Advancing health equity through linguistic inclusion in clinical trials

Ended Cooperative Agreement Awarded Last action

Award ID
U01FD008264
Recipient
Awarding agency
Obligated
$482,330

Award facts

Assistance listing
93.103 Food and Drug Administration Research
Completion date
Funding agency
Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
Place of performance
Connecticut, USA

Award details come from USAspending.gov.

Description

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.

Transactions

Action Obligated Date
Amendment -$17,670
Amendment $0
Amendment $250,000
Original award $250,000

Subawards

Subrecipient Amount Awarded
Trustees Of Boston University Luis R. Alvarez-Hernandez, Ph.D., LICSW, Assistant Professor at the School of Social Work, will co-lead the qualitative research design, bilingual data… $92,818

Quick answers

Who received award U01FD008264?

U01FD008264 was awarded to University Of Connecticut Health Center by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on August 1, 2024.

How much is award U01FD008264 worth?

$482,330 has been obligated on U01FD008264.

Which agency awarded U01FD008264?

FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008264, with funding from Office of the Commissioner (Food and Drug Administration).

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