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Fig. 2 | BMC Medical Research Methodology

Fig. 2

From: Optimal designs for phase II/III drug development programs including methods for discounting of phase II results

Fig. 2

Graphical illustration of (adjusted) utility-based optimization. The treatment effect estimate of phase II may be adjusted for the decision rule (selection s1 {u, s2} and/or for the calculation of the number of events for phase III (selection s2 {λ, αCI, u}). The utility (including the costs and the gain) is optimized over the number of events for phase II d2, the threshold value for the decision rule HRgo, and the adjustment parameter s2 = λ or αCI (see Section 2.5 for details), ξi event rate in phase i = 2, 3, bj = bj(T3) benefit categories j = 1, 2, 3

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