ROC Analysis for Phase II Group Sequential Basket Clinical Trial

Authors

  • Sirao Wang Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University, Washington DC 20057, USA
  • Ao Yuan NIH Clinical Center, Rehabilitation Medicine Department, Bethesda, MD 20892, USA
  • Larry Tang NIH Clinical Center, Rehabilitation Medicine Department, Bethesda, MD 20892, USA
  • Hong Bin Fang Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University, Washington DC 20057, USA
  • Ming T. Tan Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University, Washington DC 20057, USA
  • Leighton Chan NIH Clinical Center, Rehabilitation Medicine Department, Bethesda, MD 20892, USA

DOI:

https://doi.org/10.6000/1929-6029.2017.06.01.3

Keywords:

Basket trial, group sequential clinical trial, nonparametric ROC curve, parametric ROC curve, phase II clinical trial.

Abstract

The basket trial is a recent development in the clinical trial practice. It conducts the test of the same treatment on several different related diseases in a single trial, and has the advantage of reduced cost and enhanced efficiency. A natural question is how to assess the performance of the group sequential basket trial against the classical group sequential trial? To our knowledge, a formal assessment hasn’t been seen in the literature, and is the goal of this study. Specifically, we use the receiver operating characteristic curve to assess the performance of the mentioned two trials. We considered two cases, parametric and nonparametric settings. The former is efficient when the parametric model is correctly specified, but can bemis-leading if the model is incorrect; the latter is less efficient but is robust in that it cannot be wrong no matter what the true data generating model is. Simulation studies are conducted to evaluate the experiments, and it suggests that the group sequential basket trial generally outperforms the group sequential trial in either the parametric and nonparametric cases, and that the nonparametric method gives more accurate evaluation than the parametric one for moderate to large sample sizes.

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Published

2017-02-27

How to Cite

Wang, S., Yuan, A., Tang, L., Fang, H. B., Tan, M. T., & Chan, L. (2017). ROC Analysis for Phase II Group Sequential Basket Clinical Trial. International Journal of Statistics in Medical Research, 6(1), 22–33. https://doi.org/10.6000/1929-6029.2017.06.01.3

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General Articles