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Middle Development Trials

In: Principles and Practice of Clinical Trials

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  • Emine O. Bayman

    (University of Iowa)

Abstract

Phase I trials are the first application of the new treatment on humans. The main goal of the phase I trial is to establish the safety of the new treatment and determine the maximum tolerable dose for use in subsequent phase II clinical trial. When moved from phase I to phase II trial, the focus shifts from toxicity (safety) to efficacy. In phase II trials, the aim is to decide whether the new treatment is sufficiently promising relative to the standard therapy so that the new treatment can be included in a large-scale phase III clinical trial. In this chapter, first frequentist one-arm two-stage phase II clinical trials will be introduced. Then, a brief background for Bayesian trials will be provided. Finally, one-arm Bayesian design using predictive probability approach will be explained. Calculations or software to implement the examples will also be provided when available.

Suggested Citation

  • Emine O. Bayman, 2022. "Middle Development Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 56, pages 1031-1045, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_81
    DOI: 10.1007/978-3-319-52636-2_81
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