Background. Recently we completed a project and explored the enrichment factors that can be used to increase the ability of the clinical trial to demonstrate the treatment effect. The analyzed data is from a randomized, double blind, placebo-controlled Phase 3 clinical trial conducted in multinational centers.

Purposes and Assumptions.  Using the analysis data from this study, a series of analyses on patients’ baseline measurements in the ITT population were performed with two purposes:  1) to identify a group of patients (enriching group) who might have greater benefit from the treatment; or 2) a large placebo responders.  In terms of the disease characteristics, demographic factors, such as age, gender, and age-gender interaction were first assumed to be potential enriching factors. Meanwhile, the medical history, disease severity at baseline and concomitant drug usage as well as their interactions were also assumed to have influence on the drug effects. Read more