In this invited panel session, panelists will make formal presentations or opening remarks on the various aspects of multinational trials and related topics within the context of international statistical harmonization issues.
Multinational trials can offer significant advantages in facilitating the drug development process.
It can shorten the amount of time required for dossier development and registration. Consequently, multinational trials have become more and more appealing to drug developers all over the world. Significant experiences with multinational clinical trials have been gained through clinical research in Eastern and Western Europe, Africa, Australia, Japan and North and South America. These experiences will be reviewed and their bearing on the future will be discussed. Worldwide dossier submission involves achieving a consensus on a variety of complicated issues, including an overall study plan, disease definitions, designs, comparators, endpoints, statistical methodology, and presentation of results in light of legislation and regulatory requirements, culture, language, social welfare system and other pertinent factors.