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Transparency, Reproducibility, and Replicability of Pharmacoepidemiology Studies in a Distributed Network Environment

    Basic Details

    Our objective is to describe how the U.S. Food and Drug Administration (FDA)'s Sentinel System implements best practices to ensure trust in drug safety studies using real-world data from disparate sources.

    We present a stepwise schematic for Sentinel's data harmonization, data quality check, query design and implementation, and reporting practices, and describe approaches to enhancing the transparency, reproducibility, and replicability of studies at each step.


    Ashish Rai, Judith C. Maro, Sarah Dutcher, Patricia Bright, Sengwee Toh

    Corresponding Author

    Ashish Rai; Division of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Pilgrim Health Care Institute; Harvard Medical School, Boston, MA