Methods of Randomization: Overview and Application in Small Clinical Trials

Abstract

Background:  This manuscript is a guide to help students in their preparation to design a clinical study. Randomized clinical trials are required to investigate different therapeutic approaches and their efficacy.

Discussion: The authors discuss the great importance of a well-applied randomization technique as a fundamental tool to increase the internal validity of a clinical study. Applying a didactic approach, we use examples of studies in different areas to demonstrate the efficacy of randomization and the different methods to perform it.

Conclusion: After years of study, the large numbers of benefits of randomization are unquestioned. It is a fantastic tool to fight and avoid bias, boosting statistical power to the research. For a small sample size, some different randomized methods such as stratified randomization may avoid unbalance and validate the outcomes.