Biostatistics and Bioinformatics in Clinical Trials

Abstract Biostatistics and bioinformatics pertain to the acquisition and interpretation of quantitative information in medical research. Both disciplines involve data analysis and experimental design. No sharp delineation exists between the two, but bioinformatics tends to deal with data in many dimensions, so-called “big data,” such as in genomics. Both disciplines are concerned with conducting inferences and measuring evidence on the basis of observed data, and thus use similar tools and methodology. Relative to bioinformatics, biostatistics is an old discipline. However, the biostatistical aspects of this chapter are modern and describe responses to challenges arising from recent advances in cancer biology. The goal of the chapter is to convey an understanding of new approaches in clinical trial design and analysis.