Statistical issues in the design, conduct and analysis of two large safety studies.

@article{Gaffney2016StatisticalII,
  title={Statistical issues in the design, conduct and analysis of two large safety studies.},
  author={Michael Evan Gaffney},
  journal={Clinical trials},
  year={2016},
  volume={13 5},
  pages={
          513-8
        }
}
BACKGROUND/AIMS The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. METHODS Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article… CONTINUE READING

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