EMA Guide To Help Regulators Assess Subgroup Analyses In Confirmatory Trials

 
• By Vibha Sharma

A new final guidance by the European Medicines Agency outlines broad principles and strategies that regulatory assessors can use when investigating subgroups in confirmatory clinical trials.

Render illustration of Clinical Trial title on medical documents
EMA Guide Explains Importance Of Subgroup Analysis In Regulatory Decision-Making • Source: Shutterstock

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