A Case Study of Clinical Endpoint Bioequivalence Study with Missing Data and Non-compliance Data

Abstract

Missing data and non-compliance data questions are especially important in evaluating locally acting generic drugs because primary equivalence analyses in clinical endpoint bioequivalence (BE) studies are based on the per-protocol (PP) population (generally, completers and compliers). However, no case studies have been reported to address the status of missing data and non-compliance in clinical endpoint BE studies. A case study using a clinical endpoint study for topical drugs for treatment of acne vulgaris was used to illustrate the extent and pattern of drop out and non-compliance reported in the Sun et al. meta-analysis results, and whether drop out and non-compliance are random or not random, independent or correlated with each other, balanced or not balanced between the generic (TEST) and the innovator drug, i.e., the reference listed drug (RLD).