Statistical Analysis Plan - Multi-Analyst meta-analysis of individual patient data on Esketamine and Suicidality

Abstract

The goal is to explore the reproducibility of independent analyses conducted by three teams, consisting of the PhD students from the SHARE-CTD project. Each team has a clinical and a statistical expert assigned. The task for every team is to conduct an IPDMA assessing the efficacy of esketamine in reducing suicidality among patients with major depressive disorder. The SHARE-CTD datathon provides a unique opportunity to investigate this task in a multi-team analysis. Access to the clinical trial data is granted via the YODA project, for which a master protocol was submitted to YODA.

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