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Presentation for HL7 RCRIM and Clinical Genomics SIG

Explore genetic testing, clinical trials, and lab advancements in viral and human genetics. Discuss models, prototypes, and future extensions in pharmacogenomics and microarray data interpretation. Collaboration with HL7-I3C-CDISC-FDA efforts for streamlined processes.

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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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