A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

We describe a collaborative process and provide free software for eliciting the required prior information and calibrating operating characteristics through simulation. We illustrate the use of our procedure with a case study composed of a combination of real and simulated data. Our procedure provides good operating characteristics for detecting higher than expected rates of adverse events in the drug treatment group, and is appropriate for inferring the rate of adverse events in multi-armed clinical trials with blinded data.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Product Safety Source Type: research