ABSTRACT
ICH E9, ‚nalized and adopted by the regulatory bodies of the European Union, Japan, and the United States on February 5, 1998, includes a section (Section 3.2) on multicenter trials. It acknowledges that the inclusion of multiple centers is necessary not only to complete a trial in a reasonable time frame but also to provide a broad patient base for inference. The need for large mortality and morbidity endpoint trials in the cardiovascular area started the trend for multinational trials in the 1980s. The majority of the nations in these early multinational trials were Western industrial countries. Data from these trials were used to support product registration in the United States and Europe initially and the rest of the world subsequently.
