Regulatory Benefit-Risk Assessment and Comparative Effectiveness ResearchStrangers, Bedfellows or Strange Bedfellows?

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.