Optimising the quality and effectiveness of risk : benefit appraisal methodologies utilised in randomised control trials

This investigation systematically assesses the quality and effectiveness of risk:benefit appraisal methodologies implemented in the analysis of published randomised controlled trials for pre-licensure biomedical innovations - therapeutics, devices and surgical procedures. The key finding is that, to date, reported applications of risk:benefit methodologies are highly heterogeneous and poorly reflective of the stakeholder needs assessed in the investigation.