Regulatory Benefit-Risk Assessment and Comparative Effectiveness Research

@article{Garrison2010RegulatoryBA,
  title={Regulatory Benefit-Risk Assessment and Comparative Effectiveness Research},
  author={Professor Louis P. Garrison},
  journal={PharmacoEconomics},
  year={2010},
  volume={28},
  pages={855-865}
}
Over the past 5 years, we have witnessed growing interest in both comparative effectiveness research (CER) and regulatory benefit-risk assessment (BRA). Both deal with benefits and harms, although at different stages of the product lifecycle. There are growing pressures for a more systematic and quantitative approach to regulatory BRA. However, there is also a need for CER–beyond the evidence that can reasonably be generated during prelaunch product development. Important regulatory and policy… CONTINUE READING

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