The recent development and application of gene microarray technologies have clearly demonstrated that genomic technologies will transform biomedical research and will accelerate translation research from bench to bedside. Despite these early successes, genomic technologies have yet to produce any major drugs or diagnostic agents.
To ensure the continuing success of these recent innovations, it is of critical importance to understand the unique technological and scientific issues associated with microarrays, many of which are of a statistical nature. These statistical issues include identification and quantification of variation sources, study designs, protocols for quality controls, and analytic methods.
While these issues have always been important for general biomedical research, they are particularly significant to translational research, for example, developing innovative diagnostic tests for early detection.