Transcription of E 9 Statistical Principles for Clinical Trials
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E 9 Statistical Principles for Clinical Trials
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged September 1998 CPMP/ICH/363/96 ICH Topic E 9 Statistical Principles for Clinical Trials Step 5 NOTE FOR GUIDANCE ON Statistical Principles FOR Clinical Trials (CPMP/ICH/363/96) TRANSMISSION TO CPMP February 1997 RELEASE FOR CONSULTATION February 1997 COMMENTS REQUESTED BEFORE June 1997 FINAL APPROVAL BY CPMP March 1998 DATE FOR COMING INTO OPERATION September 1998 EMEA 2006 2 Statistical Principles FOR Clinical Trials ICH Harmonised Tripartite Guideline Table of Contents I 4 Background and Purpose .. 4 Scope and Direction.
follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the
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