The impact of the international guideline entitled Statistical Principles for Clinical Trials (ICH E9).

At the time of writing, the ICH E9 Note for Guidance entitled "Statistical principles for clinical trials" has been in force in Europe, Japan and the U.S.A. for almost a year. The purpose of this paper is to review the initial progress of E9 in terms of its degree of acceptance and also in terms of any early problems which have emerged. A different means of exploring these questions has been adopted in each of the three regions. From Europe there is a regulatory perspective on statistical issues which have been found to be incompletely covered within E9 and which have been important for specific regulatory decisions. From the U.S. there is a report of the results of a survey of U.S. pharmaceutical industry opinion concerning the effect of E9 on statistical practice in drug development. From Japan there is a discussion of the shortage of qualified statisticians in Japan and the difficulties that this causes when trying to implement E9. Some overall conclusions are drawn.

Duke Scholars

Author Frank Wesley Rockhold Biostatistics & Bioinformatics, Division of Biostatistics