In conclusion, our framework expands the scope of safety statements that can be made in emerging prospective drug safety monitoring systems. We expect that this approach will be more useful to various stakeholders than the current approach that relies simply on
tests of null hypotheses that one drug is no less safe than another. As false positivity is a major concern in prospective monitoring systems, the proposed framework will reduce the burden of false positives that is statistically significant but does not require clinical and regulatory actions.