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HCLSIG/Drug Safety and Efficacy/Scenarios/Genetic Diagnostic CT
DSE Scenario: Genetic Diagnostic CT
- 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
- Candidate samples (for CYP-allele based recruitment) at last candidate screening visit
- Study Samples at second visit taken for colon marker analysis and possible later genome-wide analysis
- EDC on a CT study that will use genotype (biomarkers) to track potential tox signals
- Raw data SDTM bundling and linking of observations with genotype (from GeneChip data)
- Analysis of SDTM data between interventions and outcomes (and genertation of ADaM ); statistics, correlation, and association
- Final bundling of analyzed data and CT interpretations
- Storage of Clinical findings for clinical mining by other investigations
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