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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

The European Medicines Agency has issued guidance for assessors at EU regulatory agencies on how they should assess subgroup analyses in confirmatory clinical trials that are presented in marketing authorization applications.

The guideline - which may also be useful to clinical trial sponsors and regulatory assessors involved in providing scientific advice to companies - describes broad principles and assessment strategies and...

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