American, Japanese, and European regulatory guidelines on biostatistics issues are compared and the content of these guidelines reviewed with respect to biostatistical aspects. Important issues concerning planning, interim analysis, multicenter studies, multiplicity, study population, and active control studies are discussed in detail. The authors' assessment of the extent to which these issues are specifically addressed in the guidelines is rated.
Food and Drug Administration (FDA).Guideline for the format and content of the clinical and statistical sections of new drug applications. Rockville, Maryland; 1988.
2.
Japanese Ministry of Health and Welfare (MHW). Announcement no. 20. Guidelines on the statistical analysis of clinical studies. 1992.
3.
European Commission: Committee for Proprietary Medicinal Products (CPMP).Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. III/3630/92-EN. 1994.
4.
European Committee Note for Guidance.Good Clinical Practice on Medicinal Products in the European Community. III/3976/88-EN. 1990.
5.
International Conference on Harmonization (ICH).Structure and Content of Clinical Study Reports. Draft 8 rev. 1. 1994.
