Coordination of American and European Research Studies

Abstract

Research and development (R&D) costs from laboratory to bedside average over $250 million throughout the world. Merck & Co. in 1991 spent over $1 billion on the research and development of compounds. International coordination is pivotal in the overall planning and execution of global R&D efforts. Placement of trials depends on the geographic, social, and economic factors of the disease. Coordination of these studies is carried out by one central team of experts which designs and implements a worldwide operational plan. Local considerations are generally accepted and regarded as a benefit as long as the basic core study objectives are not affected. In addition to the core safety and efficacy trials, Phase IV postmarketing surveillance studies are becoming one of the key mechanisms for evaluating a drug's true safety profile in clinical practice.