Multiplicity Issues in Clinical Trials BfArM 2010

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Multiplicity symposium at the BfArM (Federal Institute for Drugs and Medical Devices) in Bonn, Germany on October 12, 2010 organized by Norbert Benda (BfArM).


The symposium included several presentations and a panel discussion and focused on methods for dealing with multiple tests in clinical trials. Novel methods, their applications and regulatory acceptance were discussed with statisticians and clinicians from industry, academia, BfArM and IQWIG.


Presentation slides are available at the BfArM web site.

Introduction and Regulatory Aspects

Presented by Norbert Benda, BfArM.

Gatekeeping Strategies in Clinical Trials

Presented by Alex Dmitrienko, Eli Lilly and Company.

Graphical Approaches to Multiple Testing

Frank Bretz, Medizinische Hochschule Hannover.

Dealing with Multiplicity in Systematic Reviews and Meta-Analyses

Ralf Bender, IQWIG.