Pharmacovigilance studies without a priori hypothesis: systematic review highlights inappropriate multiple testing
Louis Gaucher1, Pierre Sabatier2, Sandrine Katsahian3
1HeKA INSERM, INRIA Paris, Centre de Recherche des Cordeliers Paris, Université Paris Cité, Paris, France.
Journal of Clinical Epidemiology
|September 1, 2023
Summary
This review of pharmacovigilance studies found limited statistical methods and no consensus on multiple testing correction. Guidelines are recommended to enhance the rigor of these important drug safety analyses.
Area of Science:
- Pharmacovigilance
- Biostatistics
- Drug Safety
Background:
- Systematic review of statistical methods in pharmacovigilance studies lacking a priori hypotheses.
- Analysis of studies published between 2012 and 2021.
Approach:
- Included 92 studies from the MEDLINE database.
- Analyzed database type, statistical methods, drug classes, and adverse drug reactions.
- Focused on disproportionality analysis using frequentist or Bayesian approaches.
Key Points:
- Pharmacovigilance databases were the most utilized.
- Anti-infectives, nervous system drugs, and antineoplastics were commonly studied drug classes.
- No standardized multiple testing correction procedure was identified.
Conclusions:
- Limited statistical methods are employed in hypothesis-free pharmacovigilance research.
- Lack of a consensus method and insufficient attention to multiple testing correction were observed.
- Development of guidelines is suggested to improve study performance and reliability.
Keywords:
Bayesian methodsDatabase analysisDisproportionality analysisFrequentist methodsMultiple testing correctionPharmacovigilanceSignal detectionSystematic reviewMore Related Videos
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