The International Conference on Harmonization guideline "Statistical Principles for Clinical Trials": Issues in applying the guideline in practice

The International Conference on Harmonization (ICH) guideline "Statistical Principles for Clinical Trials" was adopted by the Committee for Proprietary Medicinal Products in March 1998, and consequently is operational in Europe. In October 1998 a one-day discussion for urn a,as held in London by Statisticians in the Pharmaceutical Industry (PSI), The aim of the meeting was to discuss how, statisticians were responding to some of the issues in the guideline, and to document consensus views where they existed. The forum was attended by industrial, academic, and regulatory statisticians. This paper outlines the questions raised, resulting discussions, and consensus views reached.