The Interpretation of Laboratory Data

Abstract

The interpretation of laboratory tests depends upon setting up clinical studies in such a way that the maximum amount of useful and relevant information can be gained. Thus, it is important to optimize the conditions for obtaining the results. This in turn means that at least a reasonable understanding of what each parameter means is needed, and that the best conditions for its performance and what factors may interfere with the data are known. To do this properly requires good understanding and planning for the drug's development and good liaison with the investigator(s), the laboratory, and those persons responsible for reporting and presenting the data.

This paper provides an overview as to how and why certain parameters in routine laboratory assessments are measured. The errors that can occur to confound the interpretation are listed with their possible consequences. Once familiar with the possible problems associated with laboratory performance and data presentation, then interpretation is greatly facilitated. Nevertheless, because the emphasis for each drug is different, few hard and fast generalizations can be made and it is left to the reader to decide, with or without the advice of an expert, what the data mean.