Middle Development Trials

Emine O. Bayman ()
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Emine O. Bayman: University of Iowa

Chapter 56 in Principles and Practice of Clinical Trials, 2022, pp 1031-1045 from Springer

Abstract: 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.

Keywords: Phase II; Clinical trial; Bayesian; Predictive probability; Two-stage design (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_81

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DOI: 10.1007/978-3-319-52636-2_81

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