Masked Monitoring in Clinical Trials — Blind Stupidity?

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Abstract
In randomized clinical trials of treatment, information about which subjects are receiving the new treatment and which are receiving the standard treatment is often withheld from both the researchers and the subjects. Such masking is a reasonable precaution to prevent bias. However, many trials have a special monitoring committee to decide when to stop or modify a trial, and this committee is also often asked to review masked data. Monitoring committees review interim results to make certain continued randomization does not expose one group of subjects to inferior treatment.14 When a significant difference emerges, enrollment is stopped or the . . .

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