Biostatisticians play a crucial role throughout the entire process when bringing a new product to market. Their role includes much more than analyzing data at the end of a clinical study. Most importantly, statisticians need to understand the scientific and clinical questions to develop accurate strategies to answer the questions and parameters measured by statistical relevance. There is great value to having the statistician on board for the whole product development process.
Solid communication between team clinicians and statisticians is paramount for successful design, monitoring, analyses, and reporting of clinical trials. The statistician specializes in study design, accurately defining endpoints, calculating the right sample size, and ensuring correct randomization. Without assessing these statistical measures accurately, issues can arise, such as missing data or inaccurate calculations and randomization.
It’s essential to include the statistician from the beginning when bringing a new product to market to maximize clinical trial management success. The process begins with the study protocol and the statistical analysis plan, which outlines how data will be analyzed and displayed in tables and figures. While the clinician is the expert in the medical component, statisticians understand the complexities of the data associated with specific therapeutic areas and the respective statistical methodology needed to analyze the data.