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).

Highlights

  • Missing data and non-compliance are very common in clinical trials [1]

  • The latter three categories were excluded from the PP population except those dropouts due to noted lack of efficacy (LOE) (0.4% in three consecutive doses and were non-compliant; 6.3% (TEST) and 0% in reference listed drug (RLD))

  • In total, 80.1% of the TEST subjects and 77.7% of the RLD subjects were included in the PP population and used in the primary equivalence analysis between TEST and RLD

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Summary

Introduction

Missing data and non-compliance are very common in clinical trials [1]. They are especially important in clinical endpoint bioequivalence (BE) studies for evaluating locally acting generic drugs because the primary equivalence analyses are usually based on the per-protocol (PP) population (generally, completers and compliers). Sun et al [2] presented the results from a metaanalysis using six approved Abbreviated New Drug Application (ANDA) based on clinical endpoint BE studies for topical drugs as an example and reported the missing data and non-compliance data status in these ANDA studies. We give one case study to illustrate the prevalence and breakdown categories of drop out and non-compliance, 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 and the innovator drug

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