Fig. 2

Role of simulations for design and analysis of infectious disease intervention trials. Simulations (red) can provide inputs to the usual process of statistical analysis (purple) by which considerations of trial population, choice of intervention and control intervention, randomization scheme, estimands and estimators, and sample size lead to a choice of design (blue). The simulations take assumptions about the transmission setting of the trial, the individual-level effects of the intervention and the trial itself, and an approach to gathering data from the trial, and create a database of simulated results from many stochastic realizations of the trial. This database contains information on the mean and variability of quantities that would be estimated in the trial under various conditions, which can then inform the design choices