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QSPI Multiplicity Lecture Series

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The online lecture series on key multiplicity issues in clinical drug development organized by the QSPI Multiplicity Working Group was created in Fall 2012. Jeff Maca (Quintiles) currently chairs the online lecture series.

2012 presentations

December 13: The update on the EMA multiplicity guideline by Norbert Benda, Federal Institute for Drugs and Medical Devices (BfArM), Bonn. Download the slide set.

2013 presentations

January 16: Subgroup identification using SIDES (Subgroup Identification based on Differential Effect Search) by Ilya Lipkovich, Center for Statistics in Drug Development, Quintiles. Download the slide set.

February 20: Key multiplicity issues in confirmatory trials by Alex Dmitrienko, Center for Statistics in Drug Development, Quintiles. Download the slide set.

May 15: Multistage gatekeeping procedures: Enhancing flexibility and power with retesting by George Kordzakhia, U.S. Food and Drug Administration. Download the slide set.

June 19: Advanced gatekeeping procedures based on Hommel test by Thomas Brechenmacher, Novartis. Download the slide set.