Methodological/Statistical Guidances

EMA

Complete list in:

 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580032ec4

 

·         CPMP/ICH/363/96. ICH E9 Statistical Principles for Clinical Trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500002928, last access: 08-Nov-2010.

·        EMEA Scientific Guidelines for Human Medicinal Products, Clinical Efficacy and Safety Guidelines, General Guidelines. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000085.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580027549&jsenabled=true, last access: 08-Nov-2010.

·         CHMP/EWP/2459/02. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials planned with an adaptive design. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003616 , 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: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500090116, last access: 08-Nov-2010.

·         CPMP/EWP/1776/99 Rev1. Guideline on Missing Data in confirmatory trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500096793, 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: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003657,  last access: 08-Nov-2010.

·         CPMP/EWP/908/99. Points to Consider on Multiplicity issues in Clinical Trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003640, last access: 08-Nov-2010.

·        CHMP/EWP/5872/03 Corr. Guideline on Data Monitoring Committees. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003635 , last access: 08-Nov-2010.

·        CPMP/EWP/2158/99. Guideline on the Choice of the Non-Inferiority Margin. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003636, last access: 08-Nov-2010.

·        CPMP/EWP/482/99. Points to Consider on Switching between Superiority and Non_inferiority. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003658 , last access: 08-Nov-2010.

·        CPMP/EWP/2863/99 Points to Consider on Adjustment for baseline Covariates. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003639, last access: 08-Nov-2010.

 

 

ICH

·         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

·         http://www.equator-network.org

 

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

http://www.equator-network.org/resource-centre/library-of-health-research-reporting/

 

Data Monitoring Committees

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