Recommendations on the statistical analysis of the Comet assay


  • This article is published in Pharmaceutical Statistics as a special issue Focusing on the PSI Special Interest Groups, edited by John Stevens, Centre for Bayesian Statistics in Health Economics, ScHARR, Regent Court, 30 Regent Street, Sheffield, South Yorkshire, S1 4DA, UK.

Jonathan Bright, Discovery Statistics, AstraZeneca R&D, Macclesfield, Cheshire, UK.



In 2010, the Statisticians in the Pharmaceutical Industry (PSI) Toxicology Special Interest Group met to discuss the design and analysis of the Comet assay. The Comet assay is one potential component of the package of safety studies required by regulatory bodies. As these studies usually involve a three-way nested experimental design and as the distribution of the measured response is usually either lognormal or lognormal plus a point mass at zero, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with several different methods applied within the pharmaceutical industry itself. This article summarises the PSI Toxicology Group's discussions and recommendations around these issues. Copyright © 2011 John Wiley & Sons, Ltd.