400 Exploring the Diversity of Expanded Access Patients at Michigan Medicine

Abstract

OBJECTIVES/GOALS: Lack of diversity within clinical trials is well known, but there is little data on the use of investigational products through other pathways, such as expanded access. This project sought to determine the demographic diversity of patients benefiting from expanded access at Michigan Medicine. METHODS/STUDY POPULATION: Previous quality improvement reviews provided the list of 271 patients for whom a single-patient, expanded access request had been approved by the FDA and University of Michigan IRBMED between 2005 and 2021. Demographic information was collected through the EMERSE tool, including age, legal sex, race, ethnicity, and zip code. These data were cross-referenced with available regulatory documentation on product requested, treatment area, and date of request. Descriptive statistics were performed using Excel. RESULTS/ANTICIPATED RESULTS: Patients who were approved to use an investigational product through expanded access at Michigan Medicine showed a wide geographic distribution, including 48 Michigan counties, 20 states, and 1 province. All age groups were served, with those between 30-49 underrepresented and those under 10 and over 60 overrepresented. Race data generally followed the proportions of the Michigan state census, including 76% white and 14% black or African American (expected: 79% and 14%) and 48% female (expected: 50%). On further breakdown, populations differed by specialty and county. DISCUSSION/SIGNIFICANCE: The distribution of Michigan Medicine patients with approved expanded access requests was similar to the population of Michigan with respect to age, sex, and race. Further research is needed to determine if this reflects equitable use or if these results are generalizable to other institutions.