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 Tripartit
evaluation of clinical trials of an investigational product in the context of its overall clinical development. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.
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