Why must the protocol specify the principal features of the proposed statistical analysis before starting?

• A. To enable post-hoc data dredging.
• B. To ensure objective, pre-specified analysis and interpretation.
• C. To limit data collection.
• D. To expedite regulatory review.

Answer: (B)

Pre-specifying the main statistical analyses in the protocol ensures that the study’s conclusions will be objective and based on planned criteria rather than on what the data happen to show after the fact. By detailing which endpoints are primary, which statistical methods will be used, how missing data will be handled, which analysis population will be analyzed (for example, intention-to-treat vs. per-protocol), and how multiplicity or interim analyses will be addressed, the study sets a clear, defendable framework for interpreting results.

This upfront plan helps prevent bias from post hoc choices or data-driven “fishing” for significant findings, and it supports credible, transparent interpretation that regulators and independent reviewers can trust. While exploratory analyses can be conducted later, they should be described as exploratory and not used to define the primary conclusions.