SAFE is a new two-layer framework that assesses drug safety in clinical trials by analyzing synergy areas with compelling evidence and controlling FDR across areas, as shown in simulations and real-data case studies.
Perspective: Multiplicity and Subgroups in the Context of Benefit–Risk Assessment.Statistics in Biopharmaceutical Research2016; 8(4): 404–408
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Synergy Area with FDR-controlled Evaluation (SAFE) to robustly assess safety profile in clinical trials
SAFE is a new two-layer framework that assesses drug safety in clinical trials by analyzing synergy areas with compelling evidence and controlling FDR across areas, as shown in simulations and real-data case studies.