c212: Methods for Detecting Safety Signals in Clinical Trials Using Body-Systems (System Organ Classes)

This software package implements a number of methods for the detection of safety signals in Clinical Trials based on groupings of adverse events by body-system or system organ class. The methods include an implementation of the Three-Level Hierarchical model for Clinical Trial Adverse Event Incidence Data of Berry and Berry (2004) , an implementation of the same model without the Point Mass (Model 1a from Xia et al (2011)), and extended Bayesian hierarchical methods based on system organ class or body-system groupings for interim analyses. The package also implements a number of methods for error control when testing multiple hypotheses, specifically control of the False Discovey Rate (FDR). The FDR control methods implemented are the Benjamini-Hochberg procedure, the Double False Discovery Rate, the Group Benjamini-Hochberg and subset Benjamini-Hochberg methods. Also included are the Bonferroni correction and the unadjusted testing procedure.