Draft ICH Guidance on Drug Trial Statistical Principles

Federal Register notice: FDA has made available an International Council for Harmonization draft guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The document is intended to clarify, update, and extend the earlier ‘‘E9 Statistical Principles for Clinical Trials’’ in two main areas. With estimands, it discusses how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The draft is also intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products. To view the notice, click here.