Analysis of adverse events of LC in clinical trial patients

The high incidence of cancer and the resulting death toll has led pharmaceutical companies to search for new products. During the clinical phase, an essential tool for studying the safety of a product is the knowledge and analysis of AEs. During monitoring and audits, among other problems, AEs of haematological and haemochemical origin were the least identified. In the review of some biotech product reports, it was found that only 8 AEs had been identified and documented, which suggested a more in-depth analysis of the LC data in order to identify and classify AEs and to demonstrate whether or not there was underreporting. In this study, 5 DBs were used, from which tables of laboratory values outside the normal range were formed, and these values were classified according to intensity. Of the 5 DBs, 582 AEs were obtained, 574 new AEs were found in this study. These results indicate that during the stages through which an AE passes to be detected, there is non-compliance with the GCP, which causes under-reporting in the safety data of a product.

Autorentext

Licenciatura em Ciências Farmacêuticas, 2000. MsC em Ciências Laboratoriais Clínicas, 2007, IFAL, UH. Tecnóloga de 1º Nível, 2009. Monitor de Investigação Clínica e Responsável pela gestão do EAS no Centro de Imunologia Molecular. Autor e co-autor de mais de 10 publicações e artigos apresentados em eventos científicos nacionais e internacionais.