Implementation of quantitative integral analysis in assessing events associated with safety issues during clinical trials: focusing on trastuzumab

The authors developed a methodology for an in-depth study of the safety of pharmacotherapy based on a quantitative integrated analysis of adverse events in the context of clinical trials. The methodology was tested using data obtained during a bioequivalence study of trastuzumab.

Objective. Practical implementation of the approaches developed by the authors for the individualized assessment of safety of pharmacotherapy based on quantitative integral analysis of adverse events.

Materials and methods. This five-step algorithm modifies information regarding registered adverse events during clinical trials. Subsequent integral assessment of adverse drug events, in which each event is assigned a certain score and weighting coefficient, followed by aggregation of data to obtain an integral indicator at the system-organ and organism levels.

Conclusions. The algorithms proposed by the authors of the article for a systematic analysis of adverse events associated with the use of trastuzumab allow us to predict the safety of prescribed pharmacotherapy and, in the future, move to a risk-based approach when using this drug at the post-registration stage.

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