IMPALA’s newest publication has been released in the April 2024 version of Therapeutic Innovation & Regulatory Science. In this paper, IMPALA member representatives validate the open-source R package {simaerep}, which was developed to facilitate rapid, comprehensive, and near-real-time detection of AE under-reporting at each clinical trial site. This package leverages patient-level AE and visit data for its analyses. To validate its efficacy, three member companies from IMPALA consortium independently assessed the package, and share the results.
We encourage you to read the publication here, and learn more about {simaerep}!
Authors include: Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller, Michaela Mattheus, Ioannis Spyroglou, Sandra Donevska & Timothé Ménard On behalf of the IMPALA Consortium
