(C) A Dashboard to Visualize the Geographic Distribution of Incidence and Prevalence of Diseases by Race and Ethnicity in the United States Using Real-World Data

Publication Number: 1002

Background: Guidance from the United States (US) Food and Drug Administration (FDA) was published in November 2020 to promote diversity of clinical trials populations. The need for greater inclusiveness presents challenges for research on the safety and efficacy of novel therapies.

Objectives: The objectives of this research were to estimate, from real world data sources (including administrative claims), the incidence and prevalence of various diseases in the US by race and ethnicity, and develop a visualization tool to aid in interpretation of the data.

Methods: To estimate the incidence and prevalence of different indications by race and ethnicity in the US, data were obtained from several different sources, with US Census data underpinning the population estimates. The county level was selected as the geographic measure to visualize the results. For cancer types, data were obtained from the North American Association of Central Cancer Registries (NAACCR) and the Surveillance, Epidemiology, and End Results (SEER) program. For non-oncology diseases, PharMetrics Plus (PM) and the Truven MarketScan Research Multi-State Medicaid Database were used. Incidence and prevalence of non-oncology diseases were estimated at the state level using the PM database, and the racial distribution was estimated from Truven Medicaid. In some cases, racial/ethnicity breakdowns from the literature were used instead of Medicaid claims data. For all diseases, due to the sparsity of data, the incidence and/or prevalence at the racial/ethnic state level were assumed to be consistent within a state. A visualization tool was then built on top of the data.

Results: Fifteen oncology and 5 non-oncology diseases were included in the first iteration of the diversity dashboard. The dashboard allows for the easy filtering and selection by several parameters. The user can select the disease, incidence or prevalence metric, race/ethnicity category, population characteristics such as county population size, and the number of incident or prevalent cases diagnosed annually. Tool tips allow the user to see the number of incident or prevalent cases in a county, as well as the population size of the county. Additional features such as research site advocacy and community-based organization locations can be included as well.

Conclusions: Visualization of real-world data with the overlay of race and ethnicity may provide a better understanding of the diversity of patient populations in the US and enable informed decisions and actions for participant awareness, engagement, and recruitment. It is hoped that such efforts will lead to clinical trial populations that are more reflective of the real world and aligned with the epidemiology of the disease studied.