Methodological/Statistical Guidances


Complete list in:


·         CPMP/ICH/363/96. ICH E9 Statistical Principles for Clinical Trials. URL:, last access: 08-Nov-2010.

·        EMEA Scientific Guidelines for Human Medicinal Products, Clinical Efficacy and Safety Guidelines, General Guidelines. URL:, last access: 08-Nov-2010.

·         CHMP/EWP/2459/02. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials planned with an adaptive design. URL: , last access: 08-Nov-2010.

·        EMA/CHMP/EWP/117211/10. Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials. URL:, last access: 08-Nov-2010.

·         CPMP/EWP/1776/99 Rev1. Guideline on Missing Data in confirmatory trials. URL:, last access: 08-Nov-2010.

·        CPMP/EWP/2330/99. Points to Consider on Application with 1.) Meta-analyses and 2.) One Pivotal study (May 2001). URL:,  last access: 08-Nov-2010.

·         CPMP/EWP/908/99. Points to Consider on Multiplicity issues in Clinical Trials. URL:, last access: 08-Nov-2010.

·        CHMP/EWP/5872/03 Corr. Guideline on Data Monitoring Committees. URL: , last access: 08-Nov-2010.

·        CPMP/EWP/2158/99. Guideline on the Choice of the Non-Inferiority Margin. URL:, last access: 08-Nov-2010.

·        CPMP/EWP/482/99. Points to Consider on Switching between Superiority and Non_inferiority. , last access: 08-Nov-2010.

·        CPMP/EWP/2863/99 Points to Consider on Adjustment for baseline Covariates. URL:, last access: 08-Nov-2010.




·         E3 Structure and Content of Clinical Study Reports

·         E6 Good Clinical Practice : Consolidated Guideline

·         E8 General Considerations for Clinical Trials

·         E9 Statistical Principles for Clinical Trials

·         E10 Choice of Control Group and Related Issues in Clinical Trials




Non-Regulatory guidances:

EQUATOR: Enhancing the QUAlity and Transparency Of health Research



For CONSORT, STROBE, MOOSE, QUORUM and other reporting guideline go to


Data Monitoring Committees

·         Damocles Study Group. Lancet 2005; 365:711-722