📝 SummarXiv

Abstract

We introduce a Bayesian nonparametric inference approach for aggregate adverse event (AE) monitoring across studies. The proposed model seamlessly integrates external data from historical trials to define a relevant background rate and accommodates varying levels of covariate granularity (ranging from patient-level details to study-level aggregated summary data). Inference is based on a covariate-dependent product partition model (PPMx). A central element of the model is the ability to group experimental units with similar profiles. We introduce a pairwise similarity measure, with which we set up a random partition of experimental units with comparable covariate profiles, thereby improving the precision of AE rate estimation. Importantly, the proposed framework supports real-time safety monitoring under blinding with a seamless transition to unblinded analyses when indicated. Using one case study and simulation studies, we demonstrate the model's ability to detect safety signals and assess risk under diverse trial scenarios.