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Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control

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  • Mourad Tighiouart
  • André Rogatko

Abstract

The main objective of cancer phase I clinical trials is to determine a maximum tolerated dose (MTD) of a new experimental treatment. In practice, most of these trials are designed so that three patients per cohort are treated at the same dose level. In this paper, we compare the safety and efficiency of trials using the escalation with overdose control (EWOC) scheme designed with three or only one patient per cohort. We show through simulations that the number of patients per cohort does not impact the proportion of patients given therapeutic doses, safety of the trial, and efficiency of the estimate of the MTD. Additionally, we present guidelines and tabulated values on the number of patients needed to design a phase I cancer clinical trial using EWOC to achieve a given accuracy of the estimate of the MTD.

Suggested Citation

  • Mourad Tighiouart & André Rogatko, 2012. "Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control," Journal of Probability and Statistics, Hindawi, vol. 2012, pages 1-16, October.
    • Handle: RePEc:hin:jnljps:692725
    DOI: 10.1155/2012/692725
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    Cited by:

    1. José L. Jiménez & Mourad Tighiouart, 2022. "Combining cytotoxic agents with continuous dose levels in seamless phase I‐II clinical trials," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 71(5), pages 1996-2013, November.

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