Abstract 1555: An automated cage-based method of randomized group distribution in pre-clinical in vivo studies

Abstract

Abstract To more closely emulate clinical research methodology, researchers are increasingly utilizing clinically-similar group randomization and distribution methods for oncology studies in animals. It has been common practice to re-house animals into new cages with new cagemates following randomized group distribution. In male animals in particular, this frequently results in high levels of stress, injury and sometimes death due to fighting to re-establish social dominance hierarchies. Since some animals suffer more and others less, based on their relative position within the newly-established hierarchy, the levels of stress vary across the study subject population. The full impact of such stress on anticancer agent efficacy is not known but is widely believed to significantly diminish study integrity. For this reason, many researchers do not re-house male animals, choosing instead to co-house animals from various groups. It is believed that the exposure of cagemates to test agents in excreta and saliva during grooming as well as significantly increasing the risk of accidental mis-dosing can likewise negatively impact study integrity. The commonly-used manual and spreadsheet-based randomization methods do not enable cage-based randomized distribution based on qualitative or quantitative parameters. Commercially available pre-clinical trial applications now offer a solution to the above-mentioned problems.Randomization or distribution of animals based on the mean tumor volume or other parameters within the same cage allow for distribution to groups based on cage means. The variety of cage-based randomization methods available include: pure randomization, stratified sampling randomization and block randomization across multiple numeric parameters. Also, deterministic and matched-pair distribution methods can be used as well.Subjects in cages may be excluded initially based on recorded qualitative observations, and then by acceptable value ranges for numeric parameters. ANOVA results of group means are displayed instantly to ensure similarity between groups. Using software to perform standardized cage-based randomization and distribution is more clinically relevant, mitigating the negative impacts associated with post-randomization re-housing of animals. This significantly decreases the negative impact on study integrity relative to spreadsheet-based methods. Note: This abstract was not presented at the meeting. Citation Format: Eric M. Ibsen, Jeffrey L. Kumer. An automated cage-based method of randomized group distribution in pre-clinical in vivo studies. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 1555. doi:10.1158/1538-7445.AM2015-1555