Study design: think 'scientific value' not 'p-values'.

Abstract

Statistically based experimental designs have been available for over a century. However, many preclinical researchers are completely unaware of these methods, and the success of experiments is usually equated only with 'p < 0.05'. By contrast, a well-thought-out experimental design strategy provides data with evidentiary and scientific value. A value-based strategy requires implementation of statistical design principles coupled with basic project management techniques. This article outlines the three phases of a value-based design strategy: proper framing of the research question, statistically based operationalisation through careful selection and structuring of appropriate inputs, and incorporation of methods that minimise bias and process variation. Appropriate study design increases study validity and the evidentiary strength of the results, reduces animal numbers, and reduces waste from noninformative experiments. Statistically based experimental design is thus a key component of the 'Reduction' pillar of the 3R (Replacement, Reduction, Refinement) principles for ethical animal research.