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Vaccimonitor

Print version ISSN 1025-028XOn-line version ISSN 1025-0298

Abstract

PENA, María de los A et al. Proposal of an algorithm to assess causality of adverse events in vaccine clinical trials. Vaccimonitor [online]. 2008, vol.17, n.3, pp.21-26. ISSN 1025-028X.

During clinical trials it is common to appoint a commission which is in charged of assessing the causality of adverse events which are reported and transcribed to the collection data logbooks. To be able to answer the question: "Does the vaccine under study cause an adverse event.?" different pathways could be taken by decision makers, so it is obvious that the final conclusion could vary too much and a poorly assessment can generate mistaken conclusions. That confirms the need of having a procedure to define which categories must be used to analyze and to classify the relation of causality. To create an algorithm is one answer to the question. We reviewed the literature and did not find any algorithm which could be considered a "master key" to set or to reject causality, so this paper aims at designing an algorithm beginning with the international methodology used in post commercialization. A first proposal was designed which was individually and collectively analyzed by the multi-disciplinary group of the Medical Management from Finlay Institute. Finally, the proposed algorithm was approved by consensus, which could be useful to apply in clinical trials inside and outside of the institution.

Keywords : Causality; Clinical trials; Adverse events; Vaccines; Algorithm; Data logbook.

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