THE MULTINATIONAL CLINICAL-TRIALS - DESIG N, MANAGEMENT AND COSTS

The development of new drugs requires increasingly the performance of large multinational clinical trials (MCT) with a common protocol. They must be planned when the demonstration of a hypothesis, which require s specific conditions (for example availability of patients with rare diseases, a particular infrastructure or expert knowledge in trial cen ters) has to be proven in an acceptable time. Our own experience has s hown that such multinational trials are more time-consuming in their p reparation and their analysis than multicenter trials which are run in one country. MCTs are associated with complex problems due to many di fferences in medical culture, treatment strategies, administrative gui delines, etc., between countries. When possible MCTs should be realize d in countries and centers with relatively similar medical practices. A global coordination is necessary to control the progress of the tria l in the different countries. The major requirements for the successfu l realisation of an MCT, from the writing of the first draft of the pr otocol until the publication of the results, are a well-coordinated mu ltidisciplinary team and an effective project management.