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. 2015 Aug:270:82-7.
doi: 10.1016/j.expneurol.2015.02.024. Epub 2015 Feb 26.

Statistical considerations for preclinical studies

Inmaculada B Aban  1 , Brandon George  2
Affiliations

Statistical considerations for preclinical studies

Inmaculada B Aban et al. Exp Neurol. 2015 Aug.

Abstract

Research studies must always have proper planning, conduct, analysis and reporting in order to preserve scientific integrity. Preclinical studies, the first stage of the drug development process, are no exception to this rule. The decision to advance to clinical trials in humans relies on the results of these studies. Recent observations show that a significant number of preclinical studies lack rigor in their conduct and reporting. This paper discusses statistical aspects, such as design, sample size determination, and methods of analyses, that will help add rigor and improve the quality of preclinical studies.

Keywords: False positive; Missing data; Multiple outcomes; Power; Preclinical studies; Randomization; Sample size.

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Figures

Figure 1
Figure 1
Stages of Drug Development
Figure 2
Figure 2
Power Analysis for comparing two independent groups: two-tailed 5% significance level t-test assuming a common standard deviation of 20 grams and a mean of 400 grams for untreated group
Figure 3
Figure 3
Sample treatment assignment schemes
See this image and copyright information in PMC

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