Expectations for an International Harmonized Guideline

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use efficacy topic no. 9 Expert Working Group is developing a harmonized guideline for statistical considerations in clinical trials. The European Union, the United States, and Japan have their own separate guidelines for biostatistical issues. This paper briefly introduces the current Japanese statistical guideline, and identifies its problems: 1. Global evaluations as the primary endpoints, 2. Active control equivalence trials, and 3. Highly technical notes. Also provided are comments on multicenter trials and safety evaluations covered in the most recent guideline developed by the European Union. It is hoped that the harmonized guideline under development will foster faster clinical development of new drugs and the recognition of the necessary role of the biostatistician as a key member of a clinical research team.