Alosh Mohamed, Huque Mohammad F, Koch Gary G
a Division of Biometrics III , Office of Biostatistics, OTS, CDER, FDA , Silver Spring , Maryland , USA.
b Office of Biostatistics, OTS, CDER, FDA , Silver Spring , Maryland , USA.
J Biopharm Stat. 2015;25(6):1161-78. doi: 10.1080/10543406.2014.971169. Epub 2014 Oct 20.
Substantial heterogeneity in treatment effects across subgroups can cause significant findings in the overall population to be driven predominantly by those of a certain subgroup, thus raising concern on whether the treatment should be prescribed for the least benefitted subgroup. Because of its low power, a nonsignificant interaction test can lead to incorrectly prescribing treatment for the overall population. This article investigates the power of the interaction test and its implications. Also, it investigates the probability of prescribing the treatment to a nonbenefitted subgroup on the basis of a nonsignificant interaction test and other recently proposed criteria.
