TL14: Sample Size and Subgroup Analyses
*Hope Knuckles, Abbott 

Keywords: Diagnostic, sample size, subgroup

For diagnostic clinical trials, subgroups are often unknown entities. In some recent publications, subgroups have been found to have very different diagnostic characteristics - such as different cutoffs, different means, different risk factors. This roundtable will be an idea exchange about powering the subgroup and/or other methods for calculating sample size and considering subgroup analyses. This is especially difficult when powering studies for each subgroup could be difficult due to rare conditions or difficulty in obtaining consent for patients with acute illness or emergency care is needed.