Overview of ICH E8 (R1) Guideline

Abstract

ICH E8 “General Considerations for Clinical Trails” is a guideline on general considerations for the conduct of both individual clinical trials and overall development strategy for new medicinal products to support approval of the product. The guideline was developed in 1997 and had never been revised ever since then. Clinical studies these days use a broader range of study designs and data sources. In addition, an opinion has been advocated recently in which quality of clinical studies should be improved proactively by designing quality into the study protocol and processes rather than by reviewing and monitoring of document and data. Based on such background, ICH E8 has been revised, and here we present an overview of the ICH E8 (R1) “General Considerations for Clinical Studies” and a development process of this guideline from the standpoint of regulatory members in the Expert Working Group in this article.