A large multicenter double-blinded randomized placebo-controlled study is being planned to evaluate a new medication. Primary endpoints addressing mortality benefits are chosen, and a comprehensive analysis strategy is specified, including for predefined subgroups.
In discussing the advantages of this study design, which of the following represents a benefit of randomization?

Question

A large multicenter double-blinded randomized placebo-controlled study is being planned to evaluate a new medication.  Primary endpoints addressing mortality benefits are chosen, and a comprehensive analysis strategy is specified, including for predefined subgroups.
In discussing the advantages of this study design, which of the following represents a benefit of randomization?

Quizplus · Accepted Answer

The rationale behind randomization is to ensure that the groups being studied differ from one another only in terms of the intervention. As a result of the random assignment of participants to different groups, all the characteristics of these participants should be equally distributed between those groups. This controls for known and unknown variables that may have an impact on the outcome. (Choice A) Randomization is performed at the entry point of the study rather than at the analysis stage. (Choice C) Even if randomization is performed, this does not ensure that the result will be statistically significant as there may be no real difference between the groups studied. (Choice D) The sampling strategy ensures that the sample is representative of the population, but it is possible to randomize a nonrepresentative sample. (Choice E) Randomization facilitates, rather than prevents, concealing group assignments from both participants and investigators (so that neither can know nor predict the group to which a patient is assigned). This is an important part of a double-blinded randomized trial. Educational objective: Randomization distributes known and unknown variables equally among the study groups. __________

A Large Multicenter Double-Blinded Randomized Placebo-Controlled Study Is Being Planned