Interpreting clinical laboratory data in safety assessment studies

Traditionally, clinical laboratory data in safety assessment studies have been analyzed statistically to determine potential treatment-related effects. This has often led to inappropriate and/or controversial conclusions about clinical laboratory findings that are statistically significant but considered biologically unimportant. To overcome these problems, a decision-making process that integrates statistical analyses and sound medical judgement is required. Understanding the reasons why false-positive and false-negative results occur is the first step toward both better test selection and more accurate decisions on test material effects.