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Key Multiplicity Issues in Clinical Trials
Program Code:
143
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
CHAIR
:
Alex Dmitrienko,
PhD (SCHNON), Executive Director, Center for Statistics in Drug Development,
Quintiles Inc., United States
Alex Dmitrienko, Ph.D., Executive Director, Quintiles Innovation, has been actively involved in biostatistical research with emphasis on multiplicity issues. He has authored/edited two SAS Press books and a Chapman and Hall/CRC Press book. He is a Fellow of the American Statistical Association.
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SPEAKER
(S):
Mohammad Huque,
PhD (SPKAGY), Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER,
FDA, United States
Education: Ph.D. in Statistics, 1973 University of Missouri; Fellow of American Statistical Association 2004 1997- Present: Division Director for the Division of Biometrics IV at the Center Drug Evaluation and Research, FDA
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Ralph B. D'Agostino, SR, PhD,MA (SPKSUP), Chair, Mathematics and Statistics Department, Boston University, United States
Alex Dmitrienko, PhD (SPKNON), Executive Director, Center for Statistics in Drug Development, Quintiles Inc., United States
Description
This session will discuss key multiplicity issues arising in confirmatory clinical trials, including commonly used statistical methods, regulatory considerations presented in the draft FDA multiplicity guidance and case studies.