• Fundam Clin Pharmacol · Jun 2004

    Review

    Choice of designs and doses for early phase trials.

    • Yinghui Zhou.
    • Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading RG6 6FN, Berkshire, UK.
    • Fundam Clin Pharmacol. 2004 Jun 1; 18 (3): 373-8.

    AbstractThis paper reviews state-of-art statistical designs for dose-escalation procedures in first-into-man studies. The main focus will be on studies in oncology, as most statistical procedures for phase I trials have been proposed in this context. Extensions to situations such as the observation of bivariate outcomes and healthy volunteer studies are also discussed. The number of dose levels and cohort sizes used in early phase trials are considered. Finally, this paper raises some practical issues for dose-escalation procedures.

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