Sample size calculations in clinical research should also be based on ethical principles

Bruno Mario Cesana, Paolo Antonelli

Sample size calculations based on too narrow a width, or with lower and upper confidence limits bounded by fixed cut-off points, not only increase power-based sample sizes to ethically unacceptable levels (thus making research practically unfeasible) but also greatly increase the costs and burdens of clinical trials. We propose an alternative method of combining the power of a statistical test and the probability of obtaining adequate precision (the power of the confidence interval) with an acceptable increase in power-based sample sizes.