A two armed optimal response adaptive randomization for ordinal categorical responses with possible misclassification

Abstract

A two-treatment optimal target proportion is developed extending the idea of Hu et al. (2006) for phase III clinical trials, where the treatment outcomes are ordinal categorical in nature. Some response-adaptive procedures targeting this proportion are studied assuming the presence of some possible misclassification in the patient responses. The concept of asymptotically best design is also proposed in this setup. Two data studies, one from a clinical trial of patients with sports-related knee injury and another with postoperative nausea and vomiting (PONV), are also included for the assessment of the proposed procedures in real situations.

Keywords:

• Asymptotically best design
• Optimal response-adaptive design
• ordinal categorical responses

ACKNOWLEDGMENTS

The author thanks the anonymous reviewers, the Editor, and the Associate Editor for their insightful comments, which led to an improvement over the earlier version of this work.

CONFLICT OF INTEREST

The author has no conflicts of interest to report.