The "RCT augmentation": a novel simulation method to add patient heterogeneity into phase III trials.
Helene KarcherShuai FuJie MengMikkel Zöllner AnkarfeldtOrestis EfthimiouMark BelgerJosep Maria HaroLucien AbenhaimClementine Nordonnull nullPublished in: BMC medical research methodology (2018)
Simulating the inclusion of real-world subpopulations into an RCT before running it allows for quantification of the impact of each re-inclusion upon effect detection (statistical power) and generalizability of trial results, thereby explicating this trade-off and enabling a controlled increase in population heterogeneity in the RCT design.