Sample size re-assessment leading to a raised sample size does not inflate type I error rate under mild conditions

摘要

BackgroundOne major concern with adaptive designs, such as the sample size adjustable designs, has been the fear of inflating the type I error rate. In (Stat Med 23:1023-1038, 2004) it is however proven that when observations follow a normal distribution and the interim result show promise, meaning that the conditional power exceeds 50%, type I error rate is protected. This bound and the distributional assumptions may seem to impose undesirable restrictions on the use of these designs. In (Stat Med 30:3267-3284, 2011) the possibility of going below 50% is explored and a region that permits an increased sample size without inflation is defined in terms of the conditional power at the interim.