ABSTRACT
In clinical research, it is often of interest to determine whether the observed clinical results from the original target patient population (e.g., adults) can be generalized to another similar but different patient population (e.g., pediatrics or elderly). Under certain assumptions, it can be shown that the effect sizes adjusted for standard deviation between two patient populations differs by a factor, which is usually referred to as a sensitivity index. If the confidence interval of the sensitivity index is totally within a pre-specified equivalence limits, then we conclude that the clinical results from the original target patient population can be generalized to the similar but different patient population. In this chapter, the generalizability of clinical results is assessed by evaluating the sensitivity index under different models that (1) shift in location parameter is random, (2) shift in scale parameter is random, and (3) shifts in both location and scale parameters are random. An example concerning an asthma clinical trial is presented for illustration of the proposed method for assessing generalizability of the observed clinical results from adults to elderly population.
