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Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making
Session Chair(s)
Adam F Cohen, MD, PharmD, FACC, FFPM
Chief Eecutive Officer
Centre for Human Drug Research, Netherlands
This session will follow the life of a biomarker from the nonclinical arena to its use in clinical trials. The characteristics of a useful biomarker will be discussed. Examples of protocol designs and statistical analysis approaches that use mechanism of action at the molecular level to inform go/no-go decisions will be discussed.
Learning Objective : Describe the characteristics of a useful biomarker; Illustrate examples of protocol designs and statistical analysis approaches at the molecular level.
Speaker(s)
Experimental Studies
Adam F Cohen, MD, PharmD, FACC, FFPM
Centre for Human Drug Research, Netherlands
Chief Eecutive Officer
Quantitative Approaches to Design and Analysis of Experimental Medicine Clinical Trials
Gengqian Cai, DrSc
GlaxoSmithKline, United States
Director, Statistics and Programming
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