A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations

Background Large comparative clinical trials usually target a wide-range of patients population in which subgroups exist according to certain patients’ characteristics. Often, scientific knowledge or existing empirical data support the assumption that patients’ improvement is larger among certain subgroups than others. Such information can be used to design a more cost-effective clinical trial. Purpose The goal of the article is to use such...