Personalized Medicine: Separating the Hope from the Hype
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*Stephen Senn, University of Glasgow 

Keywords: drug-device co-development, targeted therapies, biomarkers

The sequencing of the human genome brings with it the hope that greater understanding of genetic components of disease will allow the more specific targeting of therapies. The hope is that it will allow sponsors to run "cleaner" clinical trials with less variability and a consequent saving in patient numbers. Speakers in this session will discuss statistical issues relating to trial design and analysis from the perspectives of academia, industry and the FDA.