Clinical trials allow scientists to take a peek at benefit-risk of a drug. The reality, however, is that drug development is complicated and understanding of a drug’s risk-benefit profile emerges over time, even way beyond regulatory approval for marketing. The assessment of benefit-risk is not trivial and requires deep understanding of the drug, and corresponding disease and patient population targets. Even as more data becomes available to identify patients that will more likely benefit from a specific drug, it is still not always possible to definitively predict whether benefit will outweigh the risk for a given patient—nor even to definitely establish how to best assess benefit and risk, as both are multi-dimensional. Data interpretation balancing statistical and scientific weight of evidence rather than strict adherence to significance levels will be explored.