Statistical Properties of the Design for Simultaneous Global Drug Development Program.

Recently, a design was proposed for the Simultaneous Global Drug Development Program (SGDDP) to assess the impact of ethnic factors on the effect of a new treatment for a targeted ethnic (TE) population. It used weighted Z tests to combine the information collected from the TE and non-TE (NTE) subgroups in the SGDDP based on the fundamental assumption on their shared biological commonality. In this article, we mathematically formulated this assumption as the quantitative interaction between treatment effect and subgroup.