RL23 Statistical Issus in Pharmacogenetics
*Liling Warren, GalxoSmithKline 


Pharmacogenetics holds promises to deliver better and safer medicines to patients, yet it is posing many practical and statistical challenges to become an integral part of the drug development process. From drug discovery, preclinical development, through phases of clinical trials, to post-marketing studies, different statistical issues arise when combing genetic data with patient demographic, drug safety and efficacy data. How to define analysis populations? What’s the most appropriate statistical method? How to evaluate clinical utility of the findings? How to validate interesting results prospectively? At this roundtable, we will discuss these issues, share experiences and brainstorm on how to effectively apply genetics to drug development with the goal to develop the right medicines at the right dose for the right patients.