The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available data for a giventrial. Furthermore, differences exist in thespecific requirements for data disclosure onthe ClinicalTrials.gov and European UnionDrug Regulating Authorities Clinical Trialsdatabases. The planning of disclosure ofclinical trial results must occur alongsidepreparation to author the Clinical StudyReport in order to meet this important legalobligation.
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