Physical Sciences and Mathematics Commons^™

Bayesian Item Response Theory: Statistical Inference And Power Analysis, Jason W. Bodnar

Dissertations

The regulatory pharmaceutical approval process is flawed in that industry clinical trials (ICTs) are always powered for efficacy and rarely powered for safety. The key safety parameter is the adverse event (AE). This practice may result in efficacious products with confounded safety. An ICT’s ability to be powered for detecting AE trends may improve patient safety. Therefore, this dissertation’s purpose was to determine if power analysis resulted in feasible sample sizes for substantiating AE hypotheses. AEs were modeled with three Bayesian 2PL IRT models. The unidimensional latent trait, transfusion-related AE, was modeled as a patient predisposition for experiencing an AE. …