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

FDA Collaborators: Center for Drug Evaluation and Research: Qi Liu, PhD; Shiew-Mei Huang, PhD; Johnny S.W. Lau, RPh, PhD; Rajanikanth Madabushi, PhD; Robert Temple, MD; Joseph A. Grillo, PharmD; Sadhna Khatri, PharmD, MPH; Rihana Miller, JD; Jamie Gamerman, JD; Kunal Naik, PharmD; Office of Minority Health and Health Equity (OMHHE): Christine Lee, PharmD

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

Project Start Date: September 2021

Regulatory Science Challenge

Older adults consume more medications than any other patient group yet are under-represented in evaluations of new medications. There is a need to better capture the challenges older adults may be facing by taking multiple prescribed medications, such as adverse drug effects, discontinuation of drug use, and reasons for not taking them as prescribed. Older adults commonly have multiple chronic conditions, take multiple medications, but also have functional and cognitive limitations that are not characterized in electronic health care records. Hearing and vision disorders, mobility limitations, transportation issues, financial constraints among other factors may present challenges for clinical trial enrollment and use of digital health tools during clinical trials (for example, the ability to operate, see, hear, measure, and respond). Older adults may also need assistance for daily activities or independent activities of daily living from formal or informal caregivers such as family members who also have an influence on perceptions of the burden of diseases or treatments or trial participation.

The FDA has established Patient Listening Groups designed to gain the input of patients mostly with rare or uncommon diseases and has also made efforts to link to organizations for feedback about specific medications and diseases, such as patient advocacy groups for selected cancers. Currently, no such avenue exists for incorporating patient perspective for the vast majority of more “representative” older adults. Their voice, concerns, desired outcomes, incentives and barriers to participation are key to increasing their representation in evaluation of medications and achieving outcomes important to patients.

Project Description and Goals

The goal of this project is to hear the voice of older adults with multiple chronic conditions to understand their perceptions about prescription drugs, medication safety, risk, pre-marketing evaluation, obstacles, facilitators and priorities regarding clinical trial participation, desired patient-centered outcomes and feasibility of performance and data collection (personal vs. digital).

A survey will be created and distributed via e-mailed internet links and postal mail to collect data from the study population – White, Black, and Hispanic / Latinx adults over age 65 who are taking more than five prescription medications per day. Survey data will be used to assess their general attitudes about research, and generate questions relevant to older adults. Other issues, such as obstacles or motivators, use of internet and digital technology, and acceptance or rejections of home visits, will also be assessed. . The data will also be used to describe characteristics of the study population, such as their demographics, prescription medication coverage, and medical conditions. Researchers will assess the extent to which the study population’s attitudes and beliefs toward prescription medication challenges impact their participation in drug research and approval.