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Analysis of the adverse event report in Cuban clinical assays

Abstract:

Drug safety is very important, so the report of adverse events in the clinical assays is considered an essential link. The quality of these reports was evaluated in 34 final reports of studies coordinated by the National Coordinating Centre of Clinical Assays between 1993 and 2002, and in 43 publications of clinical assays carried out in Cuba. In a questionnaire, there were collected characteristics of the study and of the adverse event report that were classified into adequate, partially adequate or inadequate. Some difficulties were found in the report, although the quality was better in the final reports that in the publications. The greatest problems were the omission of intensity data and/or severe adverse events and the little analysis of causality. This paper allowed to identify the main problems affecting the safety report. That's why, it was recommended to conduct methodological trainings on the topic, as well as to review the norms and procedures established to this end. © 2008 1999, Editorial Ciencias Médicas.