Transcription of Guideline on adjustment for baseline covariates in ...
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Guideline on adjustment for baseline covariates in ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 26 February 2015 EMA/CHMP/295050/2013 Committee for Medicinal Products for Human Use (CHMP) Guideline on adjustment for baseline covariates in clinical trials Draft Agreed by Biostatistics Working Party (BSWP) March 2013 Adoption by CHMP for release for consultation 30 May 2013 Start of public consultation 28 June 2013 End of consultation (deadline for comments) 31 December 2013 Agreed by BSWP January 2015 Adopted by CHMP 26 February 2015 Date for coming into effect 01 September 2015 This Guideline replaces Points to Consider on adjustment for baseline covariates (CPMP/EWP/2863/99) Comments should be provided using this template.
the primary analysis, and to help the sponsor with the ongoin g development of the drug. • In case of missing values in baseline covariates the principles for dealing with missing values as outlined e.g. in the Guideline on missing data in confirmatory clinic al trials (EMA/CPMP/EWP/1776/99 Rev. 1) applies.
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