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Outline

1	Questions to the Committee 1. It is proposed to collect DNA samples from all participants in clinical trials. What issues or barriers should be addressed to facilitate routine collection of DNA samples? When (under what circumstances, to what degree), should DNA be collected during drug development for use in exploratory analysis?
2	Questions to the Committee 2. A decision tree depicting the integration of pharmacogenetic studies into the drug development process is proposed. What comments and/or recommendations does the committee have on the scientific rationale and thought process embodied in the proposed decision tree?
3	Questions to the Committee 3. Different study types for clinical pharmacogenetic studies are proposed. What comments and/or recommendations does the committee have on the design of clinical pharmacogenetic studies and their proposed impact on subsequent clinical trials?