A Procedure for the Simplification and Assessment of Lab Parameters in Clinical Trials

Abstract

The article introduces two concepts which simplify the display and interpretation of lab data monitoring. The two concepts are: (1) a normalization (or standardization) of each lab value so that it can be interpreted without reference to its normal range and (2) a multivariate scoring system that combines lab parameters into functionally related groups. The technique is demonstrated with real clinical data. Several functional group scores are evaluated and a Global Score produced for individual patients at each time point. The Global Score, viewed over the course of therapy, presents a concise review of drug safety (or toxicity) for each patient and for the study as a whole. Examples will illustrate that the global score can be used as “a safety measure.”

Keywords

Drug safety evaluation Normalized lab parameters Deviations from normal range Multivariate score for lab abnormality assessment Safety measure of abnormal lab values

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