Subgroup analyses are an important part of the analysis of acomparative clinical trial. However, they are commonly overinterpreted1,2,3,4and can lead to further research that is misguided or, worse,to suboptimal patient care.
Consider a randomized, clinical trial designed to determinewhether a new treatment is more effective than an establishedtreatment and assessed with a test, based on all randomizedpatients, of the null hypothesis that the treatments have equalefficacy, as measured in terms of the primary end point. Then,subgroup analyses are conducted to assess whether differenttypes of patients respond differently to the new treatment.. . . [Full Text of this Article]
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Dr. Lagakos is a professor of biostatistics at the Harvard School of Public Health, Boston, and a statistical consultant to the Journal.
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