# The study: LatinX/HIspanic Attitudes and Perspectives on Investigations and Studies- of New Drugs: LAPIS-ND

> **NIH FDA U01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2022 · $470,387

## Abstract

Participants in clinical trials should reflect the individuals who may one day receive the therapeutic agent to
assure both efficacy and safety in clinical patient populations. People self-identifying as Hispanic/LatinX are a
rapidly growing segment of both the total U.S. population and in proportions of patients and older adults
seeking medical care. Yet, participation of older adults self-described as Hispanic/LatinX is amongst the lowest
in clinical trials to evaluate new medical therapies. There is evidence that the Hispanic/LatinX population may
respond differently to therapeutic agents due to both genetic factors as well as environmental influences. If
Hispanic/LatinX patients are not participating in clinical trials to determine the safety and efficacy of new
therapeutic agents, this presents a major gap in knowledge that is needed to use these therapeutic agents
during clinical care. Our overall goal is to understand perceptions evaluations of new medical therapies, and
obstacles, facilitators and priorities regarding participation in clinical trials from older adult Hispanic/LatinX
patients that have been under-represented in clinical trials to date. In this proposal, we focus on Hispanic/
LatinX of Mexican origin, as this population represents the largest proportion of Hispanic/LatinoX in the U.S.
Conceptually, in order to participate in medical research or clinical trials, individuals must have the capability,
opportunity, and motivation to participate. To increase representation of older Hispanic/LatinX adults in clinical
trials, it is key to identify motivational factors as well as barriers to participation. This information can only be
obtained using qualitative study designs such as focus groups or interviews. Therefore, we propose to conduct
focus groups with older adults self-identifying as Hispanic/LatinX of Mexican origin to elicit attitudes about
clinical trials of new medical therapies with the emphasis on perceived barriers and facilitators to participation.
Importantly, we will probe for perceptions of proposed new clinical trial designs such as use of digital
interfaces, community sites, and in-home visits, We will recruit from community sites as well as clinical sites
and focus groups will be conducted in community settings or by telephone in either the English or Spanish
language as preferred by participants. Our work is likely to generate new information on 1) ways in which
healthcare researchers or systems can address barriers to research participations of older Mexican Americans;
and 2) preferred formats (e.g., verbal, written) for recruitment, sites for conduct of studies, and sources of
information, types of testing that is acceptable, and 3) motivating factors for participation.

## Key facts

- **NIH application ID:** 10639980
- **Project number:** 1U01FD007777-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** JANICE B SCHWARTZ
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $470,387
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10639980

## Citation

> US National Institutes of Health, RePORTER application 10639980, The study: LatinX/HIspanic Attitudes and Perspectives on Investigations and Studies- of New Drugs: LAPIS-ND (1U01FD007777-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10639980. Licensed CC0.

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