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This page provides information on recent updates on the MultXpert web site.

January 5, 2014: Special issues

Journal of Biopharmaceutical Statistics 2014: Special issue of Journal of Biopharmaceutical Statistics on subgroup analysis in clinical trials (January 2014) guest-edited by Sue-Jane Wang (FDA) and Alex Dmitrienko (Quintiles).

August 8, 2013: Conferences

Multiplicity Issues in Clinical Trials JSM 2013: Selected presentations given at Joint Statistical Meetings in Montreal, QC on August 4-August 8, 2013.

June 24, 2013: Conferences

DIA 2013: Presentations given in the invited session on key multiplicity issues in clinical trials at the DIA Annual Meeting in Boston, MA.

May 20, 2013: Conferences

SCT 2013: Presentations given in the invited session on multiplicity issues in clinical trials at the SCT Annual Meeting in Boston, MA.

March 10, 2013: Short courses

Multiplicity Issues in Clinical Trials 2013 taught by Alex Dmitrienko at the ENAR conference in Orlando, FL.

December 17, 2012: Regulatory guidance

The U.S. Food and Drug Administration released a draft guidance document on enrichment strategies for clinical trials. See Regulatory Guidance.

December 13, 2012: Presentations

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. See QSPI Multiplicity Lecture Series.

May 30, 2012: Regulatory guidance

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. See Regulatory Guidance.

April 23, 2012: Short courses

Multiplicity Issues in Clinical Trials 2012 taught by Alex Dmitrienko at the FDA/DIA Statistics Forum in Washington, DC.

April 5, 2012: Conferences

Subgroup Analysis in Clinical Trials ENAR 2012: Selected presentations given at the ENAR Conference in Washington, DC on April 2-4, 2012.

September 20, 2011: Short courses

Key Multiplicity Problems in Clinical Trials 2011 taught by Alex Dmitrienko at the FDA/Industry Statistics Workshop in Washington, DC on September 19, 2011.

August 30, 2011: Conferences

International Conference on Multiple Comparison Procedures 2011 held in Washington, DC on August 29-September 1, 2011.

August 30, 2011: Short courses

Gatekeeping Procedures in Clinical Trials 2011 taught by Alex Dmitrienko and Ajit Tamhane at the International Conference on Multiple Comparison Procedures in Washington, DC.

August 6, 2011: Conferences

Multiplicity Issues in Confirmatory Clinical Trials: Free online conference focuses on recent advances in the area of multiple comparisons, including methods for addressing complex multiplicity problems known as gatekeeping procedures.

August 4, 2011: Conferences

Multiplicity Issues in Clinical Trials JSM 2011: Selected presentations given at Joint Statistical Meetings in Miami, FL on July 31-August 4, 2011.

April 25, 2011: Special issue

Journal of Biopharmaceutical Statistics 2011: Special issue of Journal of Biopharmaceutical Statistics on multiplicity and adaptive design issues in pharmaceutical statistics edited by Dr. Alex Dmitrienko (Eli Lilly and Company) and Prof. Martin Posch (Medical University of Vienna) is now available online.

April 9, 2011: Short courses

Key Multiplicity Issues in Clinical Trials 2011 taught by Alex Dmitrienko at the Applied Statistics Workshop in Los Angeles, CA.

January 23, 2011: Software implementation

MultXpert package: The first release of the MultXpert R package was uploaded to the CRAN web site. This package provides software implementation of commonly used p-value-based and parametric multiple testing procedures and gatekeeping procedures. The package was developed by Alex Dmitrienko, Eric Nantz and Gautier Paux with contributions by Thomas Brechenmacher.

December 6, 2010: Short courses

Gatekeeping Procedures in Clinical Trials 2010 taught by Alex Dmitrienko at the Deming Conference on Applied Statistics in Atlantic City, NJ on December 6, 2010.

November 5, 2010: Conferences

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

October 5, 2010: Short courses

Multiplicity Issues in Clinical Trials 2010: Short course taught by Frank Bretz and Alex Dmitrienko at a Société Francaise de Statistique (SFdS) meeting in Paris, France on October 14-15, 2010.

October 2, 2010: Software implementation

MultXpert package: Updated version of functions to be included in the MultXpert package which provides software implementation of commonly used p-value-based and parametric multiple testing procedures and gatekeeping procedures.

October 1, 2010: Software implementation

Implementation of Multiple Testing Procedures: SAS macros for implementing commonly used multiple testing procedures, including p-value-based procedures (adjusted p-values and simultaneous confidence intervals) and parametric procedures (adjusted p-values and simultaneous confidence intervals).

August 10, 2010: Conferences

Multiplicity Issues in Clinical Trials JSM 2010: Selected presentations at Joint Statistical Meetings in Vancouver, Canada on August 1-5, 2010, including an invited session on key multiplicity issues in clinical trials organized by Alex Dmitrienko and chaired by Yan D. Zhao.

July 10, 2010: Short courses

Multiple Testing Problems in Clinical Trials 2010: Short course taught by Alex Dmitrienko at Osaka University in Osaka, Japan on July 24, 2010.

June 30, 2010: Conferences

Multiplicity Issues in Clinical Trials ICSA 2010: Presentations given at the multiplicity session at the 2010 International Chinese Statistics Association meeting in Indianapolis, IN on June 23, 2010 organized by Alex Dmitrienko and chaired by Yan D. Zhao.

April 12, 2010: Short courses

Key Multiplicity Issues in Clinical Trials 2010: Short course taught by Alex Dmitrienko at the Indiana ASA Chapter meeting in Indianapolis, IN on April 30, 2010.