Clinical Laboratory Safety Data in Drug Studies

Clinical laboratory measurements are an integral component of most drug studies for two major reasons, firstly to act as an efficacy endpoint in monitoring the success or otherwise of therapy and secondly to ensure patient safety on any new drug or reformulation. The pharmaceutical industry rarely employs physicians and scientists with expertise in clinical laboratory medicine. As such, there is a tendency for test selection, data-management and data interpretation to be based on historical knowledge. The industry rarely involves the clinical laboratory in study design, resulting in out-of-date parameters, with little appreciation of the limitation and advantages of specific test programmes. In major clinical studies, the numerical element in a submission report may consist of 50 per cent laboratory data with many thousands of laboratory test results, which may increase to 80 per cent in phase 1, and early phase 2 studies. Thus, we are concerned with a vast volume of data, particularly related to the assessment of safety. Why do we do laboratory tests?