In the context of clinical trials, what does E9 primarily address?

E9 primarily addresses statistical principles and methodologies that are essential in the design and analysis of clinical trials. Specifically, it provides guidance on how to apply statistical theory to ensure the integrity of clinical trial data and the validity of conclusions drawn from the results. Understanding statistical principles is crucial for determining appropriate sample sizes, managing variability, and interpreting results in a manner that is scientifically sound. This framework is vital for regulatory submissions and helps ensure that the statistical analyses used are robust and suitable for making informed decisions regarding the safety and efficacy of new treatments.

This focus on statistical methodologies distinguishes E9 from other aspects of clinical trials, such as participant ethics, financial considerations, or recruitment strategies, which do not fall under its primary scope.