Likelihood-ratio-test methods for drug safety signal detection from multiple clinical datasets
Summary: Pre- and postmarket drug safety evaluations usually include an integrated summary of results obtained using data from multiple studies related to a drug of interest. This paper proposes three approaches based on the likelihood ratio test (LRT), called the LRT methods, for drug safety signal detection from large observational databases with multiple studies, with focus on identifying signals of adverse events (AEs) from many AEs associated with a particular drug or inversely for signals of drugs associated with a particular AE. The methods discussed include simple pooled LRT method and its variations such as the weighted LRT that incorporates the total drug exposure information by study. The power and type-I error of the LRT methods are evaluated in a simulation study with varying heterogeneity across studies. For illustration purpose, these methods are applied to proton pump inhibitors (PPIs) data with 6 studies for the effect of concomitant use of PPIs in treating patients with osteoporosis and to lipiodol (a contrast agent) data with 13 studies for evaluating that drug's safety profiles.
- A likelihood ratio test based method for signal detection with application to FDA's drug safety data
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- Efficient methods for signal detection from correlated adverse events in clinical trials
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- Accounting for Multiplicities in Assessing Drug Safety: A Three-Level Hierarchical Mixture Model
- False Discovery Rate Estimation for Frequentist Pharmacovigilance Signal Detection Methods
- Efficient methods for signal detection from correlated adverse events in clinical trials
- Multivariate Tests Comparing Binomial Probabilities, with Application to Safety Studies for Drugs
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