EMA advises on creating sub-groups for clinical trials

Published: 13-Feb-2014
Regulatory

Guidelines suggest how to document and plan for such trials


The European Medicines Agency (EMA) has issued guidance for pharma companies that want to devise clinical trials based on separate groups of the population. Its advice looks at how assessments can look at one gender; healthy or unhealthy patients; subjects of certain ages; or living in particular regions.

The guidelines say how to document and plan for such trials.

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