Making Sense of Biostatistics: Statistical Significance

The contributions of professional statisticians, both in designing a clinical trial and analyzing the data collected, are critical in new drug development. In addition, it is very helpful if other members of the trial’s study team have a conceptual understanding of statistical methodology to facilitate team discussions of statistical considerations. The goal of this new monthly column is to help develop this understanding. Since biological information is collected in clinical research, we’ll use the name biostatistics from now on. We will be taking a conceptual approach, with very few calculations. In the coming months, I hope to demystify biostatistics, and convince you that it really is user friendly! Biostatistics can be operationally defined as an integrated discipline that involves all of these activities (Turner, 2007, p. 4-5): • Identifying a specific research question (e.g., does an investigational antihypertensive drug lower blood pressure effectively?) • Deciding upon the design of the study, the methodology that will be employed, and the data that will be collected • Identifying the statistical techniques that will be used to describe and analyze th