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…
8 April 2019
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
8 April 2019
Internal Information

4. “Protocol” and the Semiotic Triangle Doug Fridsma (U Pitt)
“We need to sign off on the protocol by Friday”
Concept 1
Thing 1
Document
Study
“Protocol XYZ has enrolled 73 patients”
Thing 2
Concept 2
Symbol
“Protocol”
“Per the protocol, you must be at least 18 to be enrolled”
Concept 3
Thing 3
Plan
8 April 2019
Internal Information
Source: John Speakman/Charlie Mead

5. July 2004 Announcement of CDISC/SDTM as a standard format
CDISC Clinical Data Interchange Standards Consortium
RCRIM
Regulated Clinical Research and Information Management, technical committee
Relationship HL7/CDISC
HL7 “Health Level Seven”
8 April 2019
Internal Information

6. During 2006-2007 Relationship HL7/CDISC
SDTM variables as Common Data Elements & Controlled Terminologies
In OWL format
NCI Thesaurus
CDISC Clinical Data Interchange Standards Consortium
UMLS
RCRIM
Regulated Clinical Research and Information Management, technical committee
Relationship HL7/CDISC
BRIDG Biomedical Research Integrated Domain Group Model
HL7 “Health Level Seven”
8 April 2019
Internal Information

7. Ongoing work at FDA Announcement of CDISC/SDTM as a standard format
CDISC Clinical Data Interchange Standards Consortium
RCRIM
Regulated Clinical Research and Information Management, technical committee
Relationship HL7/CDISC
"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, FDA 27 January 2006
Janus Model and Data Warehouse
HL7 “Health Level Seven”
“… populate a cross-study database and do more comprehensive analyses for the benefit of patients.”
8 April 2019
Internal Information

8. FDA’s JANUS Full Model one visual representation
8 April 2019
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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?
8 April 2019
Internal Information