Abstract
In order to evaluate the effects of a particular treatment strategy on mortality and major morbidity within a disease entity, large, multinational, relatively long-term clinical endpoint studies are often conducted. The primary challenge of conducting these studies is to maintain consistency in the interpretation of the clinical endpoints across different geographic areas and over the long time course of the study. The success of a clinical endpoint study depends on understanding the challenges and incorporating the special requirements of these studies into the protocol design and operational procedures throughout the study.
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