HCLSIG/Drug Safety and Efficacy/Scenarios/Genetic Diagnostic CT

DSE Scenario: Genetic Diagnostic CT

1. Phase IIb Clinical Trial Design that includes Amplichip CYP 450 and Colon Cancer (?) Diagnostic Chips, used to identify
   • a) which CYP alleles present for drug metabolism; used to screen candidates for placement in different CT arms
   • b) linkage analysis for colon cancer contributors; for population segmentation and responder analyses
2. Candidate samples (for CYP-allele based recruitment) at last candidate screening visit
3. Study Samples at second visit taken for colon marker analysis and possible later genome-wide analysis
4. EDC on a CT study that will use genotype (biomarkers) to track potential tox signals
5. Raw data SDTM bundling and linking of observations with genotype (from GeneChip data)
6. Analysis of SDTM data between interventions and outcomes (and genertation of ADaM ); statistics, correlation, and association
7. Final bundling of analyzed data and CT interpretations
8. Storage of Clinical findings for clinical mining by other investigations