1. Os ensaios clínicos e o registro de anticorpos monoclonais e biomedicamentos oncológicos no Brasil.
- Author
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Ferreira da Silvai, Cecilia, Ventura da Silva, Míriam, and Garcia Serpa Osorio-de-Castro, Claudia
- Subjects
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THERAPEUTIC use of interferons , *THERAPEUTIC use of monoclonal antibodies , *RITUXIMAB , *BEVACIZUMAB , *IPILIMUMAB , *COLON tumors , *KIDNEY tumors , *LUNG tumors , *LYMPHOMAS , *RESEARCH methodology , *STOMACH tumors , *TUMORS , *DRUG approval , *RETROSPECTIVE studies , *THERAPEUTICS ,RECTUM tumors - Abstract
Objective. To analyze the pathway of clinical trials of monoclonal antibodies and biological medicines for cancer treatment involving Brazilian institutions from 2003 to 2012. Method. This retrospective, descriptive study was based on review of two clinical trial registries, ClinicalTrials.gov and the Brazilian registry ReBEC. Phase II or III studies with participation from Brazilian institutions listed in at least one of the registries were included. Following selection of the trials, the pathway of monoclonal antibodies and biological medicines was investigated from the research stage until licensing by the Brazilian Agency for Sanitary Surveillance (Anvisa), Food and Drug Administration (FDA), and European Medicines Agency (EMA). Results. Nine trials (eight phase III and one phase II) were selected. All had a randomized, controlled design. Two trials were double-blind and seven were open-label, and all recruited adults (> 18 years of age) of both sexes. The mean number of patients recruited per trial was 985.2. Seven trials had been completed and two had been terminated early. All trials were sponsored by non-Brazilian pharmaceutical companies and focused on renal, colorectal, gastric, and lung (non-small cell) cancer, non-Hodgkin lymphoma, and melanoma, and involved the use of cetuximab, figitumumab, ipilimumab, rituximab, bevacizumab and interferon alfa-2a. The FDA was the first agency to license the drugs, followed by EMA, except in the case of interferon alfa-2a, which was not approved by EMA. We were unable to determine the year of drug licensing by Anvisa in Brazil. Conclusions. The participation of Brazil in clinical trials of monoclonal antibodies and biological medications for cancer treatment is insufficient. The quality of the available information on trials, history of licensing, and other relevant elements is a major weakness of the sources reviewed. [ABSTRACT FROM AUTHOR]
- Published
- 2016