Sample size calculations in clinical research should also be based on ethical principlesReportar como inadecuado

Sample size calculations in clinical research should also be based on ethical principles - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.


, 17:149

First Online: 18 March 2016Received: 03 July 2015Accepted: 04 March 2016DOI: 10.1186-s13063-016-1277-5

Cite this article as: Cesana, B.M. & Antonelli, P. Trials 2016 17: 149. doi:10.1186-s13063-016-1277-5


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.

KeywordsSample size calculation Statistical power Confidence limits power Delimited confidence intervals Ethical principles AbbreviationsCCTscontrolled clinical trials

CIconfidence interval

EHstandardized expected half-width

Hjstandardized half-widths

H0null hypothesis

H1alternative hypothesis

ICHInternational Conference for Harmonization

PEH|Cprobability of obtaining standardized half-widths of sample CIs that are less than the EH, conditional on the coverage

PHj|Cprobability of obtaining standardized half-widths that are less than Hj, conditional on the coverage

Download fulltext PDF

Autor: Bruno Mario Cesana - Paolo Antonelli


Documentos relacionados