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Lancet. 2005 Apr 9-15;365(9467):1348-53.

Sample size calculations in randomised trials: mandatory and mystical.

Author information

1
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA. KSchulz@fhi.org

Abstract

Investigators should properly calculate sample sizes before the start of their randomised trials and adequately describe the details in their published report. In these a-priori calculations, determining the effect size to detect--eg, event rates in treatment and control groups--reflects inherently subjective clinical judgments. Furthermore, these judgments greatly affect sample size calculations. We question the branding of trials as unethical on the basis of an imprecise sample size calculation process. So-called underpowered trials might be acceptable if investigators use methodological rigor to eliminate bias, properly report to avoid misinterpretation, and always publish results to avert publication bias. Some shift of emphasis from a fixation on sample size to a focus on methodological quality would yield more trials with less bias. Unbiased trials with imprecise results trump no results at all. Clinicians and patients deserve guidance now.

PMID:
15823387
DOI:
10.1016/S0140-6736(05)61034-3
[Indexed for MEDLINE]

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