title: Sample size calculations in clinical research should also be based on ethical principles.
abstract: 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.
authors.affiliation: Unit of Biostatistics and Biomathematics, University of Brescia, Viale Europa 11, 25123, Brescia, Italy. bruno.cesana@unibs.it.
authors.forename: Bruno Mario
authors.initials: BM
authors.lastname: Cesana
authors.affiliation: Unit of Biostatistics and Biomathematics, University of Brescia, Viale Europa 11, 25123, Brescia, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Antonelli
mesh_terms: D035843:Biomedical Research; D016001:Confidence Intervals; D006801:Humans; D011336:Probability; D012107:Research Design; D018401:Sample Size
keywords: Confidence limits power; Delimited confidence intervals; Ethical principles; Sample size calculation; Statistical power