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Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials

We have adopted this International Scientific Guideline - EMA/CHMP/EWP/117211/2010. 

Last updated

About this guideline

End of consultation (overseas): 31 July 2010

For information: 1 August 2014

Categories: Clinical efficacy and safety | Biostatistics

TGA annotations: Nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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