Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products

This paper presents a 2015–2021 US Food and Drug Administration (FDA) Drug Trials Snapshots (DTS) Data Visualization Explorer—an interactive data visualization web-based tool (https://arielcarmeli.shinyapps.io/fda-drug-trial-snapshots-data-explorer) built in R and based on publicly available FDA clinical trial participation data and disease incidence data from the National Cancer Institute and Centers for Disease Control and Prevention. FDA data can be explored by race, ethnicity, sex, age group, therapeutic area, pharmaceutical sponsor, and approval year for clinical trials that supported each of the 339 FDA drug and biologic approvals between 2015 and 2021. This work provides several advantages relative to past literature and DTS reports: a dynamic data visualization tool; race, ethnicity, sex, and age group data presented in one place; data on sponsor; and emphasis on data distributions instead of averages. We present recommendations for improved data access, reporting, and communication to assist leaders in making evidence-based decisions to improve trial representation to enhance health equity.