Extract
Randomization in clinical trials reduces bias. Its intent is to generate
groups of patients that are comparable with each other before starting a
study. As a result, both known and unknown patient factors that may affect the
outcome under investigation are balanced between the treatment groups,
minimizing the risk of differences between the two groups at the onset of the
trial. This helps to ensure that differences in outcomes observed between the
groups are the result of the intervention. Anything that compromises the
balance of these factors may introduce bias into the
results1,2.
If an imbalance between the groups skews the results in favor of one
intervention over the other, this can lead to a biased study. Therefore, a
randomized, double-blinded, placebo-controlled (when appropriate) trial with
intention-to-treat analysis is considered to be the highest level of evidence
in clinical research. This provides the clearest insight into the effect of
the intervention being studied by controlling for as many factors as
possible.