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W3C HCLS Task Force on Drug Safety and Efficacy

Explore safety dimensions, efficacy in disease models, biomarkers, pharmacogenomics, and more in drug development. Connect clinical observations with discovery for better therapeutic outcomes.

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W3C HCLS Task Force on Drug Safety and Efficacy

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  1. W3C HCLS Task Force on Drug Safety and Efficacy Kerstin Forsberg, Bo Anderson - AstraZeneca Jim McGurk - Merck Ted Slater - Pfizer Eric Neumann - Teranode Uwe Trinks - Sentrx

  2. Focus Areas • Translational Science Perspective • Subject State Thinking (biomarkers) • Safety dimensions • Efficacy (disease models) • Animal  Human (CDISC’s SEND, SDTM/ODM) • Clinical Observations and their relation to biomarkers (+ mechanisms) and pharmacogenomics • Connecting back to Discovery • Targets • Biomarkers • Therapeutic Knowledge • Leads, Candidates selection • Mechanisms of Action • BioPAX… Internal Information

  3. Domain Semantics • Clinical Semantics • Patient/Subject  Disease state • Diagnostics  Findings • Findings  Inferred (proposed) Disease state • Disease state  Patient Classification / Segmentation • Design  Clinical trial arm / treatment • Observation  POC, safety, mechanism Internal Information

  4. Concept 1 Concept 2 “We need to sign off on the protocol by Friday” • “Protocol XYZ has enrolled 73 patients” Thing 1 Thing 2 Study Document Concept 3 Thing 3 “Per the protocol, you must be at least 18 to be enrolled” Plan “Protocol” and the Semiotic TriangleDoug Fridsma (U Pitt) Symbol “Protocol” Internal Information Source: John Speakman/Charlie Mead

  5. July 2004 Announcement of CDISC/SDTMas a standard format CDISCClinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC HL7 “Health Level Seven” Internal Information

  6. During 2006-2007 SDTM variables asCommon DataElements&ControlledTerminologies In OWL format NCI Thesaurus CDISCClinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC BRIDGBiomedical Research Integrated Domain Group Model HL7 “Health Level Seven” Internal Information

  7. "The FDA has the largest pool of randomized clinical trial data in the world, but it cannot be analyzed now because it is inaccessible" Dr. Janet Woodcock, Deputy Commissioner for Operations and Chief Operating Officer, FDA27 January 2006 Ongoing work at FDA Announcement of CDISC/SDTMas a standard format CDISCClinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC Janus Model and Data Warehouse HL7 “Health Level Seven” “… populate a cross-study database and do more comprehensive analyses for the benefit of patients.” Internal Information

  8. FDA’s JANUS Full Modelone visual representation Internal Information

  9. Proposed Notes and Activities • Notes planned • SDTM and JANUS from a SW perspective • Semantic enriched evolvable recombinant clinical observations • DEMO: Table and XML models ala RDF • Retrospective DBs (JANUS) and SW + power of annotations and links • DEMO: using URI code and RDBM • Provenance and trust (non-reputability) • ACL? Internal Information

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