Abstract
Japan's participation in global clinical trials has been steadily increasing. The ways of cooperation between Japan and foreign countries have also diversified. In the current situation of drug development, when considering whether or not Japan should participate in a global clinical trial, there are in fact many cases in which human data in a foreign population has already been obtained to some extent in drug developments lead by foreign countries. There may be cases where Japanese phase I trials are not necessarily required prior to Japan's participation in global clinical trials if safety in the Japanese population that will be included in the global clinical trial is ensured by foreign data. Based on the accumulated knowledge up to now, the “Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials” has been issued. This paper explains the necessity of phase I trials in Japanese population prior to global clinical trials, including the background of the new guidance issued and some points to consider.
