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Stopping rules for long-term clinical trials based on two consecutive rejections of the null hypothesis

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  • Mohamed Mubasher
  • Howard E. Rockette

Abstract

A strategy for stopping long-term randomized clinical trials with time-to-event as a primary outcome measure has been considered using the criteria requiring multiple consecutive (or non consecutive) rejections at a specified α-level that controls against elevation of type I error. The procedure using two consecutive rejections is presented in this work along with the corresponding α-levels for the interim tests. The boundary cutoff values for these interim levels were determined based on an overall prespecified test size and were calculated using multidimensional integration and/or simulations. The reduction in the interim α-level values that is required to maintain the experiment-wise error rate is found to be modest. The power of the test is evaluated under various alternative accrual and hazard patterns. This procedure provides a more realistic stopping rule in large multi-center trials where it may be undesirable to terminate a trial unless a sustained effect has been demonstrated.

Suggested Citation

  • Mohamed Mubasher & Howard E. Rockette, 2017. "Stopping rules for long-term clinical trials based on two consecutive rejections of the null hypothesis," Communications in Statistics - Theory and Methods, Taylor & Francis Journals, vol. 46(3), pages 1342-1351, February.
    • Handle: RePEc:taf:lstaxx:v:46:y:2017:i:3:p:1342-1351
    DOI: 10.1080/03610926.2015.1019142
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