Prespecification

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9
Current Step 4 version dated 5 February 1998
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
E9 Document History
New Codification November 2005 E9
First Codification E9
History
Date
Approval by the Steering Committee under Step 2 and release for public consultation.
16 January 1997
Current Step 4 version
E9 Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 5 February 1998 E9
STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 February 1998, this guideline is recommended for adoption to the three regulatory parties to ICH
TABLE OF CONTENTS
I. 1.1 1.2 II. 2.1 INTRODUCTION ...............................................................................................1 Background and Purpose .....................................................................................1 Scope and Direction..............................................................................................2 CONSIDERATIONS FOR OVERALL CLINICAL DEVELOPMENT........3 Trial Context.........................................................................................................3 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 2.2.7 2.3 2.3.1 2.3.2 III. 3.1 Development Plan...................................................................................3 Confirmatory Trial..................................................................................4 Exploratory Trial ....................................................................................4 Population ...............................................................................................4 Primary and Secondary Variables .........................................................5 Composite Variables ...............................................................................6 Global Assessment Variables.................................................................6 Multiple Primary Variables ...................................................................7 Surrogate Variables................................................................................7 Categorised Variables............................................................................7 Blinding ...................................................................................................8 Randomisation ........................................................................................9

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