Maximizing value and minimizing waste in clinical trial research in swine: Design features to minimize bias

Abstract

Researchers designing trials should implement design features intended to reduce bias. These include random allocation to intervention groups and blinding of caregivers and outcome assessors. The method of generating the random sequence should be reported, as well as methods for stratification or blocking if used. When blinding is not possible, objectively measured outcomes should be used. Allocation concealment may not be essential when all eligible pens or animals are enrolled and there is no preference for intervention group. An a priori trial protocol should be made publicly available, and results for all outcomes evaluated should be reported.