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**Comment: group sequential designs with response-adaptive randomisation.**
*(English)*
Zbl 07708426

Summary: Group sequential Phase III trial designs enable early stopping for positive or negative study outcomes. Response-adaptive randomisation can be included in such designs with the sampling ratio in each group of subjects determined by the current treatment effect estimate. We demonstrate the potential of adaptive randomisation to reduce the number of patients receiving the inferior treatment, even when there is a delay in observing each patient’s response. We also observe that using a fixed but unequal sampling ratio may offer a simpler way to achieve the same objectives.

### MSC:

62-XX | Statistics |

Full Text:
DOI

### References:

[1] | HAMPSON, L. V. and JENNISON, C. (2013). Group sequential tests for delayed responses (with discussion). J. R. Stat. Soc. Ser. B. Stat. Methodol. 75 3-54. · Zbl 07555437 · doi:10.1111/j.1467-9868.2012.01030.x |

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[3] | Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. CRC Press/CRC, Boca Raton, FL. · Zbl 0934.62078 |

[4] | JENNISON, C. and TURNBULL, B. W. (2001). Group sequential tests with outcome-dependent treatment assignment. Sequential Anal. 20 209-234. · Zbl 0987.62052 · doi:10.1081/SQA-100107646 |

[5] | PAMPALLONA, S. and TSIATIS, A. A. (1994). Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis. J. Statist. Plann. Inference 42 19-35 · Zbl 0805.62078 · doi:10.1016/0378-3758(94)90187-2 |

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