Fig. 1

Example 1. A DDP segment: a phase II single-arm trial followed by a phase III RCT. The results of the phase II trial trigger the termination of the segment or continuation to phase III. B The probability that the phase II trial detects treatment effects and recommends a phase III trial that subsequently confirms the positive effect of the experimental treatment. C Average number of patients enrolled in the DDP segment (i.e., in the phase II and III trials) across simulations for an effective (black line) and ineffective (red line) therapy