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Presentation for HL7 RCRIM and Clinical Genomics SIG

Presentation for HL7 RCRIM and Clinical Genomics SIG. HL7 Working Group Meeting San Diego, CA 21Jan2004. Clinical Trials Pre-Clinical (Animals) Phase I (Healthy Patients) Phase II (Small “real” patients) Phase III (Large “real” patients) Phase IV (Post Marketing).

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Presentation for HL7 RCRIM and Clinical Genomics SIG

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  1. Presentation for HL7 RCRIM and Clinical Genomics SIG HL7 Working Group Meeting San Diego, CA 21Jan2004

  2. Clinical Trials • Pre-Clinical (Animals) • Phase I (Healthy Patients) • Phase II (Small “real” patients) • Phase III (Large “real” patients) • Phase IV (Post Marketing)

  3. Genetic Testing for Clinical Trials • Inclusion / Exclusion Criteria • Drug Metabolism Data • Disease Predisposition & Progression • Gene Therapy & Efficacy • Viral Resistance Genotyping • Other Genetic Technology for Clinical Trial Testing (eg. PCR)

  4. Types of Clinical Genetic Testing • Viral Genetics • Viral Load Testing (HIV PCR Viral Load) • Viral Sequence Testing (Genotype, Phenotype & Resistance Testing) • Human Genetics • Microarray Testing • Sequencing Testing • SNP Testing

  5. Lab Subcommittee: Completed Steps • Model Prototypes • Viral Resistance Genotyping • Human Tissue Transplant Rejection Markers • Human Drug Metabolism Markers • Fit Standard Use Cases to Model • Revise model • Add Known Variant Use Cases • E.g. Reinterpretation of a Viral Sequence

  6. Lab Subcommittee: In Progress • Isolate and Standardize Common Elements • Sequence, Codon, SNP, etc. • Refine model with Standard Elements • Fit Real Data to Model

  7. Future Lab Model Extensions • Additional Pharmacogenomics Processes • Microarray Data • Scientific Extensions • Addition of nonSNP Genomic data (e.g. Introns) • Interpretation of multiple HIV Strains

  8. Next Steps • Define Relation to New HL7-I3C- CDISC-FDA Effort • Flow from Preclinical to Lab to Operational to Analysis and Submissions Models • Common Large Models with Subsetted Implementations • Refinement of Common Data Structures • Sequence, Codon, SNP, etc.

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