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Host:

University of California, San Francisco (UCSF) – Stanford University Center of Excellence in Regulatory Science and Innovation (CERSI)

Description:

Gold standards of clinical care are based on randomized blinded clinical trial data. Unfortunately, Black or African American, Hispanic or Latino and other racial and ethnic minority communities, and persons with multimorbidity or disabilities have been under-represented in clinical trials relative to their presence in the patient groups that are candidates for the treatment. Sections on CLINICAL TRIAL DIVERSITY AND MODERNIZATION are part of the 2023 Omnibus Bill in an attempt to solve the problem of under-representation in clinical trials. However, enrollment of diverse older adults with multiple chronic conditions into clinical trials will not increase unless patients are willing and able to participate.

Our goals were to elucidate the priorities and perceptions about feasibility of participation and data collection (in person vs. virtual), barriers to participation, and motivators regarding clinical trial participation by 1) surveying a nationally representative sample of older adults with multiple chronic conditions and identifying differences between gender, race and ethnicity, and between very old adults compared to younger old adults; 2) conducting focus groups in English and Mandarin with Asian communities of Chinese origin; and 3) conducting focus groups in English and Spanish with Hispanic or Latino communities.

Quantitative results from the national survey and qualitative results from the focus groups in the Asian communities of Chinese origin will be presented, and preliminary results from focus groups in the Hispanic or Latino communities will be briefly mentioned. Results that differ from “conventional wisdom” or literature based on results from other groups of adults will be the focus. Overall, our data suggest that proposed changes in clinical trial design to increase enrollment of under-represented older adults may not align with patient-reported preferences.

Presenter:

JANICE SCHWARTZ, MD, is Professor of Medicine at the University of California, San Francisco with appointments in the Department of Medicine Divisions of Geriatrics and Clinical Pharmacology. She is a board-certified internist, cardiologist and a geriatrician with significant experience in clinical research. She has been investigating cardiovascular changes with aging in animal and human models and the changes with aging that determine responses to therapeutic medications since the 1980’s—at Stanford, UCSF, Baylor, Northwestern where she was Chief of Geriatrics and Clinical Pharmacology, and the Jewish Home of SF where she was Director of Research. Her research has involved basic laboratory research, clinical trials and population research. She is the author of over 200 publications including scientific articles, reviews, and book chapters. She has been named one of the Best Doctors in the U.S. (geriatric medicine), received the 2012 William B Abrams Award in Geriatric Clinical Pharmacology from the American Society of Clinical Pharmacology and Therapeutics, and the 2019 Award for Excellence in Clinical Pharmacology from PhRMA, Foundation, Inc. She was an ORISE Visiting Professor in the Office of Clinical Pharmacology at the FDA from October 2019-November 2020 with the major goal of advocating for improving evaluation of drugs and optimizing use of therapeutic agents in older adults. Her current work focuses on understanding patient attitudes and beliefs about non-adherence and clinical trial participation. Her overall goal is to optimize medication use for the very oldest people, as well as the translation of new therapies into clinical use to benefit the very oldest and frailest patients.

For Questions and Reasonable Accommodations:

Please contact Ruize Li at Ruize.Li@fda.hhs.gov or go to Interpreting.Services@oc.fda.gov.