Guideline on adjustment for baseline covariates in clinical trials

We have adopted this International Scientific Guideline - EMA/CHMP/295050/2013.

Last updated

3 June 2024

About this guideline

Overseas effective date: 1 September 2015

Replaces: CPMP/EWP/2863/99 Points to Consider on Adjustment for Baseline Covariates (Adopted by TGA 20 May 2005)

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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