Practical Issues in Design and Management of Multinational Trials

Abstract

Multinational clinical trials to investigate drug therapy under a common protocol are becoming increasingly common in drug development. In most cases multinational trials are set up to enable—in an acceptable time period— the conduct of a study that requires specific conditions like availability of patients having a rare disease or a certain infrastructure or expertise in investigational centers. Experience at Bayer shows that study preparation and evaluation/documentation need substantially longer than for multicenter trials in one country. The problems with such trials are manifold and can be found in differences in medical practice, regulations, culture, and in organizing the trial. If a multinational trial cannot be avoided it should be restricted to countries and centers with similar medical practice. From drafting the protocol unto the publication the teamwork needs firm coordination and leadership in order to complete the study successfully.