This web site provides general information on traditional and innovative approaches to the design and analysis of clinical trials with multiple objectives, including multiple endpoints, multiple dose-control comparisons, multiple subgroups, etc.
See Index for a list of articles on the MultXpert web site.
What is new?
The U.S. Food and Drug Administration released a draft guidance document on enrichment strategies for clinical trials on December 17, 2012. See Regulatory Guidance.
The online lecture series on key multiplicity issues in clinical drug development organized by the QSPI Multiplicity Working Group was kicked off with a presentation by Norbert Benda, Federal Institute for Drugs and Medical Devices (BfArM), Bonn on December 13, 2012. See QSPI Multiplicity Lecture Series.
The CHMP (Committee for Medicinal Products for Human Use) released a concept paper on the need for a guideline on multiplicity issues in clinical trials on May 24, 2012. See Regulatory Guidance.
Subgroup Analysis in Clinical Trials ENAR 2012: Selected presentations given at the ENAR Conference in Washington, DC on April 2-4, 2012.
Visit Updates to get more MultXpert updates.
The MultXpert newsletter provides information on recent developments in the world of multiple comparisons with emphasis on clinical trial applications. To subscribe to the MultXpert newsletter, visit MultXpert Newsletter.
Multiple Testing Problems in Pharmaceutical Statistics, edited by Dr. Alex Dmitrienko (Eli Lilly and Company, U.S.A.), Prof. Ajit C. Tamhane (Northwestern University, U.S.A.) and Dr. Frank Bretz (Novartis, Switzerland; Hannover Medical School, Germany) [Chapman & Hall/CRC Press 2009]. Available on Amazon's web site.
Multiple Comparisons Using R, written by Dr. Frank Bretz (Novartis Pharma AG, Switzerland; Hannover Medical School, Germany), Prof. Torsten Hothorn (Ludwig-Maximilians-Universität München, Germany) and Prof. Peter Westfall (Texas Tech University, USA) [Chapman & Hall/CRC Press 2010]. Available on Amazon's web site.
Visit Short Courses for information on recent and upcoming short courses on multiplicity and related topics.
Visit MultXpert package to learn about the new R package for implementing popular multiple testing and gatekeeping procedures
Visit Software to find out more about other free software for implementation of commonly used multiple testing and gatekeeping procedures
This web site is maintained by a group of volunteers led by Alex Dmitrienko. We would like to thank the organizations that have generously provided funds to support this web site:
- Department of Biomedical Statistics, Osaka University Graduate School of Medicine, Osaka.
- Applied Statistics Workshop.
- Trimodal Network.