Figure 5.

Curves showing the relationship between the number of events in historical trial(s) and analytical estimates of across-trial rejection probabilities when β̂_PS,H = ln(1.58) = 0.46, β̂_ES = ln(1.1) = 0.095, and v̂ar(β̂_ES) = 4/400 = 0.01. If β_PS= (1 − 0.58)E[β̂_PS,H] , then β_ES = 0.5β_PS, and under the preservation of effect hypothesis with p = 0.5 , we wish to control the non-inferiority test rejection probability below 0.025. Synthesis(λ, p) and Bias-adjusted(λ, p) were evaluated for a range of λ and a fixed p = 0.5.