W3C HCLS Task Force on Drug Safety and Efficacy

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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

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Areas

• Translational Science Perspective
• State thinking (biomarkers)
• Safety dimensions
• Efficacy (disease models)
• Animal ? Human
• Clinical Observations relation biomarkers (
  mechanisms)
• Discovery
• Targets
• Biomarkers
• Therapeutic
• Leads, Candidates
• Mechanisms
• BioPAX

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Domain Semantics

• Clinical Semantics
• Patient ? Disease state
• Diagnostics ? Findings
• Inferred (proposed) Disease state
• Patient Classification / Segmentation
• Clinical trial arm / treatment
• Observation ? POC, safety, mechanism

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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
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During 2006-2007
SDTM variables asCommon DataElementsControlle
dTerminologies
NCI Thesaurus
In OWL format
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
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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.
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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?