Subgroup analysis refers to the practice of conducting separate analyses of clinical trial results within specific subsets or subgroups of participants from the overall trial population. It involves examining the treatment effects, outcomes, or responses to the intervention within these defined subgroups to gain a deeper understanding of how the treatment may vary across different patient characteristics or clinical factors.
In a clinical trial, participants are typically recruited from a diverse population with various characteristics, such as age, gender, disease severity, or genetic profile. Subgroup analysis allows researchers to explore whether the treatment effect is consistent across these different subgroups or if there are any variations in efficacy, safety, or other outcomes.
The purpose of subgroup analysis is to identify potential differences in treatment response and assess whether the intervention may be more beneficial or have specific risks within certain patient subgroups. By conducting separate analyses for each subgroup, researchers can investigate whether the treatment effect is influenced by specific factors and determine if any modifications or tailored approaches are warranted for specific patient populations.
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