Whatever the data source, statistical data mining methods, including Bayesian modeling, can efficiently extract safety information.

摘要

Assessment of drug safety is a primary goal in drug development and post-marketing. However, in contrast to the rigorous design and analysis of efficacy endpoints, safety events are typically unplanned and occur spontaneously. Safety data are also highly multivariate, with many possible adverse event terms. Most of these terms are very sparsely-populated in clinical trial and post-marketing data sources.