Randomization, Masking, and Allocation Concealment (2018)

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Randomized controlled trials (RCTs) are justified by many considerations— both methodological and ethical. From a methodological standpoint, the assignment of subjects to treatment arms based on random criteria is designed to prevent systematic differences from influencing the outcomes; potential differences between the arms of the trial will be “washed out” via the random procedure. Similarly, the double-blind element is designed to prevent the subjective biases of the researcher from influencing the outcome.1 From an ethical standpoint, the use of the random element is tied up with broader ideas of fairness; just as in sporting events and political debates, a chance element (e.g., a flip of a coin) is used to ensure that no side gets an unfair advantage. Also, since the results from a randomized study are more credible than observational studies without randomization, the determination of safety and efficacy might be accomplished more quickly than through unsystematic observation; when interventions pose potentially significant health risks, this is clearly a socially beneficial outcome

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