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Fig. 1 | BMC Medical Research Methodology

Fig. 1

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

Fig. 1

Graphical illustration of basic phase II/III drug development program. The drug development program consists of one exploratory phase II trial, which is, in case of a go decision (i.e., treatment effect estimate of phase II \( {\hat{\theta}}_2 \) exceeds predefined threshold value κ =  − log(HRgo)), followed by one confirmatory phase III trial, where the sample size planning is based on \( {\hat{\theta}}_2 \). The program is considered successful if phase III has a positive (significant) result (i.e., normalized log rank test statistic of phase III T3 is above the 1 − α quantile of the standard normal distribution z1 − α)

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