International conference on harmonisation; guidance on statistical principles for clinical trials; availability--FDA. Notice

Abstract

The Food and Drug Administration (FDA) is publishing a guidance entitled "E9 Statistical Principles for Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to provide recommendations to sponsors and scientific experts regarding statistical principles and methodology which, when applied to clinical trials for marketing applications, will facilitate the general acceptance of analyses and conclusions drawn from the trials.