Unlocking Stratified Randomization: A Comprehensive Guide for Phase III Clinical Trials
Stratified randomization is a critical tool for ensuring balanced representation in the treatment groups of clinical trials, particularly Phase III trials where subtle influences on outcomes can have significant effects. By dividing the participant pool into subgroups, or strata, based on characteristics known or suspected to impact the treatment response, researchers can prevent potential imbalances that could confound results. However, implementing this method requires careful planning and monitoring, with considerations around defining the strata, creating a randomization plan, enrolment and treatment assignment, ongoing monitoring, and data analysis.
