ICH E9 statistical principles for clinical trials - Scientific guideline

This document provides guidance on the design, conduct, analysis and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It also assists with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.

The addendum provides clarification on some of the concepts explained in ICH E9. It presents a structured framework for clinical trial planning, conduct, data collection and interpretation of data analyses. The addendum also refines the role of sensitivity analysis to explore robustness of conclusions from the main statistical analysis, both aligned to the same estimand.

Keywords: Statistical methodology, clinical trial design.