What statistical considerations must be made in protocol development?

In the context of protocol development, it is essential to include all statistical analyses that will be used in the study. This comprehensive approach ensures that the analysis plan is well-defined and allows for proper interpretation of the study results. By specifying the statistical methods, researchers can maintain the integrity of the study design, ensure compliance with regulatory standards, and address potential biases or confounding factors.

Including all statistical analyses not only aids in the design phase but also provides transparency for reviewers and stakeholders. It facilitates reproducibility, allowing others to understand and replicate the study methods and conclusions. Furthermore, it establishes clear endpoints for the analysis, helping to guide data collection and handling procedures.

The other options suggest a limited scope of statistical considerations, which could undermine the study's validity. For example, focusing solely on sample size or randomization methods overlooks other critical aspects such as data handling, analysis techniques, and the handling of missing data, which are vital for a robust and credible study. Therefore, a comprehensive outline of all statistical analyses in the protocol is crucial for ensuring rigor in clinical research.