Meta -analysis in the Evaluation of the Safety of Erythropoietin Stimulating Agents: Recent Experiences and Lessons Learned
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*Jesse Aaron Berlin, Johnson & Johnson Pharmaceutical R&D  *Dianne K. Tomita, Amgen 

Keywords: meta-analysis, drug safety,erythropoietin-stimulating agents

Meta-analysis is a statistical method that can be used to summarize data across multiple, roughly similarly designed studies with regard to a potential safety and/or efficacy issue associated with a product or product class. Epoetin alfa and darbepoetin alfa are two erythropoiesis-stimulating agents (ESAs) that are approved for use in the United States for oncology patients receiving chemotherapy who have developed anemia as a result of their cancer treatment. Recently, results of large clinical trials, many in related patient populations, have suggested a potential safety risk with respect to survival and disease progression. This presentation summarizes results of some of the individual trials as well as providing both study- and patient-level meta-analysis results.