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  1. Advancing Regulatory Science

The MUM-URMA1 study: Multimorbidity and Medications: the unheard perspective of older Under-Represented Racial and Ethnic Minority Adults: Phase 1

CERSI Collaborators: University of California at San Francisco (UCSF): Janice Schwartz, MD

FDA Collaborators: Office of Minority Health and Health Equity (OMHHE): Christine Lee, PharmD, PhD; Center for Drug Evaluation and Research (CDER): Qi Liu, PhD

CERSI Subcontractors: University of California, Los Angeles (UCLA): Derjung Tarn, MD, PhD

Project Start Date: September 1, 2021

Regulatory Science Challenge

Participants in clinical trials should reflect the individuals who may one day receive the therapeutic agent. Ensuring people from diverse backgrounds have the ability and motivation to participate in clinical trials is key to advancing health equity. Older adults consume more medications than any other patient group yet are under-represented in evaluations of new medications with representation of Asian Americans having amongst the lowest representation. Their voice, concerns, desired outcomes, incentives, and barriers to participation are key to increasing their representation in new therapies.

Project Description and Goals

The goal of this project is to hear the voice of older Asian adults with multiple chronic conditions to understand their perceptions about facilitators and priorities regarding clinical trial participation, desired patient-centered outcomes and feasibility of performance and data collection (personal vs. digital) during clinical trials.

Investigators will conduct focus groups with older adults (>65 years) self-identifying as Asian people taking >5 prescription medications daily recruited from community-based and clinic settings stratified by place of birth - U.S. vs. non-U.S. and then by language preference (English/Mandarin). A total of 9-12 focus groups (6-8 participants each) of no more than 90 minutes will be conducted. A focus group guidebook will be used to elicit attitudes toward participation in research evaluations of medical therapies, specifically clinical trials and potential perceived burdens of participation, barriers to participation, and motivators and facilitators for participation.

Older adults consume more medications than any other patient group yet are under-represented in evaluations of new medications with representation of Asian people having amongst the lowest representation. Our focus groups will allow their voice, concerns, and desired outcomes to be heard and identify incentives and barriers to participation that they may have to increase their representation in evaluation of medical therapies and achieving outcomes that are important to them.

 

 
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