Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data.

Biostatistics plays a key role in all phases of clinical research starting from the design to the monitoring, data collection, data analysis, and interpretation of the results. A clear understanding of the statistical framework as it relates to the study hypothesis, reported results, and interpretation is vital for the scientific integrity of the study and its acceptance in the general medical community. In this brief report, we will put in perspective the general analytical framework for exploring and validating prognostic factors using data from large databases.