Best Biostatistics Practices To Drive Clinical Trial Success

Maximizing the value of biostatistics in a clinical program requires a strategic and integrated approach from the very beginning. In this checklist, we highlight the importance of early engagement, encouraging statisticians to be involved in the earliest stages of protocol development to align on clear objectives and ensure the study design meets regulatory expectations.

The list also provides guidance on data strategy and statistical integrity. It cautions against “data fishing” and overanalyzing data without a clear hypothesis. The importance of cross-functional collaboration and clear communication is also explored, recommending that statisticians be included in all major project updates and that all assumptions and methods be clearly documented. Lastly, the checklist touches on the role of technology and regulatory oversight. View the full list to help your clinical program effectively utilize biostatistics