Analytical calculation of operating characteristics
EVENTS, EVENT
One way of comparing (i) analysis methods for SAFE and (ii) different frontiers would be to design a Monte Carlo simulation study, as is often done to evaluate novel statistical methods. However, due to both the relatively small sample size of D3 and the binary nature of both treatment and the outcome, in this specific example, we decided it was best to calculate the operating characteristics of various methods analytically, integrating over the probability of observing each number of events for any value of true control event risk. The advantage of this is that the results are exact and not affected by Monte Carlo error. Nevertheless, we present the plan for our analytical calculations here in a style similar to that recommended for Monte Carlo simulation studies [