A survey of the most common methods of group randomization and distribution in pre‐clinical in vivo studies (1053.7)

Abstract

To closely emulate clinical research methodology and improving clinical relevance, researchers are utilizing clinically‐similar group randomization and distribution methods for pre‐clinical studies in animals. One common approach, random number generator in a spreadsheet, is paradoxically the least clinically‐relevant and subject to manual and transcription errors. This method provides no easy way to exclude animals from distribution based on other parameters. Due to limitations in spreadsheet software, commercially available pre‐clinical trial applications can be used to perform the most accepted randomization and distribution methods: deterministic and matched distribution, pure randomization, stratified sampling randomization and block randomization across multiple numeric parameters. Subjects may be excluded initially based on recorded qualitative observations, and then by acceptable value ranges for numerical parameters. Animals can be randomized iteratively in rolling enrollment studies and previously randomized subjects can be re‐randomized into new groups for drug‐resistance studies. ANOVA results are displayed instantly to ensure similarity between groups. Standardizing randomization and distribution using clinically relevant methods improves the efficiency, clinical relevance, and outcome of animal studies relative to spreadsheet‐based methods.