This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 645
Type: Invited
Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305987
Title: Multiplicity in Clinical Trials: A European Perspective
Author(s): Norbert Benda*+ and Joachim Roehmel
Companies: BfArM and Institute for Prevention Research and Social Medicine
Address: , , ,
Keywords: Clinical Trials ; Multiplicity ; Europe

Soon after the ICH E9 Biostatistical guideline has been released end of 1998, European regulators required further and more detailed information on several key methodological issues that were discussed. Among these issues were "role of meta-analysis in the licensing process", "non-inferiority", and "multiplicity issues". It was the general feeling that the guidance provided by the ICH E9 document should be supplemented in order to facilitate a more effective regulatory review of new submissions. Statisticians employed by European agencies have been rare even today. The supplementary guidances therefore also aimed at strengthening the methodological basis within the 16 national agencies. I will touch briefly the main topics from the CPMP Points-to-Consider document "Multiplicity Issues in Clinical Trials" and will then address new

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