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Bethesda North Marriott Hotel and Conference Center

2015 年 04 月 20 日 8:30 上午 - 2015 年 04 月 22 日 4:30 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics 2015 Forum

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Session 6: Subgroup Analysis

Session Chair(s)

Kathleen Fritsch, PHD

Mathematical Statistician, Div. of Biometrics III, Off Biostatistics, OTS, CDER

FDA, United States

Joachim Vollmar, MSC

Joachim Vollmar, MSC

Executive Consultant

International Clinical Development Consultants LLC (ICDC), United States

Subgroup analyses are an important component of confirmatory clinical trials for assessing consistency and heterogeneity. Various stakeholders have an interest in learning if treatments have different effects in different groups of subjects. EMA is in the process of revising a guideline on subgroup analysis and FDA is in the process of publishing a white paper on the topic. This session will include presentations on the two documents and include a panel discussion regarding the application of subgroup analysis in the various regulatory settings.

Speaker(s)

Speaker

Armin Koch, DRSC

Hannover Medical School, Germany

Head, Institute of Biometry

Speaker

Mohamed A. Alosh, PHD

FDA, United States

Mathmatical Statistician

Frank Bretz, PHD

Panelists (joining the Speakers)

Frank Bretz, PHD

Novartis , Switzerland

Distinguished Quantitative Research Scientist

Estelle Russek-Cohen, PHD

FDA, United States

Senior Advisor, Office of Biostat

Alex Dmitrienko, PHD

Quintiles Inc., United States

Executive Director, Center for Statistics in Drug Development