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50. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds)
12. Jahrestagung der Deutschen Arbeitsgemeinschaft für Epidemiologie (dae)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie
Deutsche Arbeitsgemeinschaft für Epidemiologie

12. bis 15.09.2005, Freiburg im Breisgau

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Latest Issues in Regulatory Statistics: A review of the latest CHMP Biostatistical Guidelines currently under review

Meeting Abstract

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  • David J. Wright - MHRA, London

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. Deutsche Arbeitsgemeinschaft für Epidemiologie. 50. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 12. Jahrestagung der Deutschen Arbeitsgemeinschaft für Epidemiologie. Freiburg im Breisgau, 12.-15.09.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc05gmds654

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/gmds2005/05gmds286.shtml

Published: September 8, 2005

© 2005 Wright.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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This talk will focus on the key statistical issues raised in new CHMP Biostatistical Guidelines. CHMP biostatistical guidelines are written to help medical assessors in regulatory agencies across Europe evaluate the efficacy of products submitted by pharmaceutical companies to them to obtain a marketing authorisation for a medicinal product. In turn these guidelines are used by the pharmaceutical industry to aid them in designing an appropriate clinical development program for a medicinal product. In particular this talk will focus on the recently adopted CHMP Points to Consider document on the Choice of Non-Inferiority Margin and CHMP Guideline on Data Monitoring Committees. The talk will also address some of the statistical issues raised in the CHMP guideline on the use of flexible designs in confirmatory clinical trials that is currently being written.