Elaboração de um procedimento operacional padrão para análise das notificações de eventos adversos graves inesperados a medicamentos ocorridos em ensaios clínicos realizados no Brasil

Abstract

Adverse events that have occurred in clinical trials being conducted in Brazil should be notified to Anvisa, as recommended by Resolution RDC No. 9/2015. This resolution addresses, among other aspects, the safety of the participant in clinical trials and specifically in his art. 63, the resolution determines that all unexpected serious adverse events occurring in the national territory, whose causation is possible, probable or defined in relation to the product under investigation, must be notified to Anvisa. Assurance of participant safety is shared responsibility between investigators and sponsors according to Good Clinical Practices (GCPs). In this context, the objective of this work is to collect and analyze the notifications of serious adverse events submitted to Anvisa between the years 2015 and 2018 received by NotivsaEC. And, from then on, to define a procedure for the analysis of reports of unexpected serious adverse events occurring in clinical trials with medicines in national territory and then to elaborate a standard operating procedure (SOP), to be used by the responsible area in Anvisa. Among the results, some interesting information can be highlighted such as inadequate reporting of serious adverse events (SAE) from bioequivalence / bioavailability studies and expected SAE; the decrease of 21% in the number of SAE notifications received between 2015 and 2018 and the large number of studies being developed in the area of oncology. It can also be evidenced that the presence of a comorbidity has no implication in the evolution of the SAE, according to data received by NotivisaEC. Anvisa will standardize and optimize the analysis of these notifications and will be able to use this tool to evaluate the protocols of clinical trials, assistance programs and selection of tests for inspections, in addition to the preparation of the SOP - Analysis of Notifications of Serious Adverse Events received by NotivisaEC. Will also be able to identify potential risks from reported SAE and act proactively by suspending or discontinuing clinical trials being conducted in Brazil.