EXTRAPOLATION APP

to recalculate the results in Evidence, eminence, and extrapolation.

Adjust the significance level, based on prior information



1) Define the alpha level and power of the adult study program. 2) Specify the positive predictive value PPV of the adult study program, or calculate it by setting the prior belief in the alternative hypothesis before start of Phase III in adults . 3) Prespecify the PPV, the alpha level, and the power that corresponds to a conventional study program for this specific indication this indication and age group, either by: 3.a) equating them with the corresponding values in adults 3.b) setting, alpha, the power, and and the PPV for conventional study programs 3.c) setting, alpha, the power, and and the prior belief in efficacy before start of phase III for conventional studies 4) Set the belief 1-q in the alternative hypothesis in children for the case that extrapolation is not considered to be possible. 5) Set the power of the paediatric study.
Calculation of the adjusted significance level based on prior assumptions.