Likelihood comparisons in bounded outcome score analysis must be internally consistent.

Abstract

Clinical trial endpoints are often bounded outcome scores (BOS), which are variables having restricted values within finite intervals. Common analysis approaches may treat the data as continuous, categorical, or a mixture of both. The appearance of BOS data being simultaneously continuous and categorical easily leads to confusions in pharmacometrics regarding the appropriate domain for model evaluation and the circumstances under which data likelihoods can be compared. This commentary aims to clarify these fundamental issues and facilitate appropriate pharmacometric analyses.