Multi-arm covariate adjusted response adaptive designs for ordinal outcome clinical trials

Stat Methods Med Res. 2023 Jan;32(1):88-99. doi: 10.1177/09622802221133558. Epub 2022 Oct 20.

Abstract

Covariate adjusted response adaptive designs are developed with ordinal categorical responses for phase III clinical trial involving multiple treatments. Stochastic ordering principle is used to order the treatments according to effectiveness and consequently allocation functions are developed by combining the cumulative odds ratios suitably. The performance of the proposed designs is investigated through relevant exact as well as large sample measures. To investigate the performance in a real situation, a real clinical trial involving lung cancer patients is further redesigned using the proposed allocation design.

Keywords: Covariate adjusted response adaptive design; cumulative odds ratio; ordinal categorical responses; proportional odds model..

MeSH terms

  • Humans
  • Odds Ratio
  • Research Design*