Rosa Gini, Romin Pajouheshnia, Helga Gardarsdottir, Dimitri Bennett, Lin Li, Claudia Gulea, Angelika Wientzek-Fleischmann, Marloes T Bazelier, Mehmet Burcu, Caitlin Dodd, Carlos E Durán, Sigal Kaplan, Stephan Lanes, Karine Marinier, Giuseppe Roberto, Kanaka Soman, Xiaofeng Zhou, Robert Platt, Soko Setoguchi, Gillian C Hall
PURPOSE: Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses reproducibility challenges associated with diversity across real-world data sources (RWDS) repurposed for secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe and characterize practices, recommendations and tools for collecting and reporting diversity across RWDSs, and explore how leveraging diversity could improve the quality of evidence...
May 2024: Pharmacoepidemiology and Drug Safety