Bayesian hierarchical model for safety signal detection in multiple clinical trials

Clinical safety signal detection is of great importance in establishing the safety profile of new drugs and biologics during drug development. Bayesian hierarchical meta-analysis has proven to be a very effective method of identifying potential safety signals by considering the hierarchical structure of clinical safety data from multiple randomized clinical trials conducted under an Investigational New Drug (IND) application or Biological License Application (BLA). This type of model can integrate information across studies, for instance by grouping related adverse events using the MedDRA system-organ-class (SOC) and preferred terms (PT).

Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Yafei Zhang, Shuai Sammy Yuan, Barry A. Eagel, Hal Li, Li-An Lin, William W.B. Wang Source Type: research