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Published in: Trials 1/2016

Open Access 01-12-2016 | Letter

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

Authors: Bruno Mario Cesana, Paolo Antonelli

Published in: Trials | Issue 1/2016

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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.
Literature
1.
2.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.CrossRef
3.
Cesana BM, Antonelli P. A new approach to sample size calculations for the power of testing and estimating population means of Gaussian distributed variables. Biomed Stat Clin Epidemiol. 2010;4:67–78.
4.
Metadata
Title
Sample size calculations in clinical research should also be based on ethical principles
Authors
Bruno Mario Cesana
Paolo Antonelli
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1277-5

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