• J Biopharm Stat · Mar 2020

    The i3+3 design for phase I clinical trials.

    • Meizi Liu, Sue-Jane Wang, and Yuan Ji.
    • Department of Public Health Sciences, The University of Chicago, Chicago, IL, USA.
    • J Biopharm Stat. 2020 Mar 1; 30 (2): 294-304.

    AbstractThe traditional rule-based design, 3 + 3, has been shown to be less likely to achieve the objectives of dose-finding trials when compared with model-based designs. We propose a new rule-based design called i3 + 3, which is based on simple but more advanced rules that account for the variabilities in the observed data. We compare the operating characteristics for the proposed i3 + 3 design with other popular phase I designs by simulation. The i3 + 3 design is far superior than the 3 + 3 design in trial safety and the ability to identify the true MTD. Compared with model-based phase I designs, i3 + 3 also demonstrates comparable performances.

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