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Translational Informatics@ UCSF
1nf0rmatics Day
June 10th, 2014
Sorena Nadaf M.S.,M.MIAssociate Director HDFCCC
Chief Informatics Officer, Director of Translational Informatics Program
“Science is evolving at an incredible pace. It’s a revolutionary period. The fundamental change is that biomedical science has converged…
Elias Zerhouni, M.D.
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3
• The landscape of clinical, basic science, and translational research has evolved and is still rapidly changing
• Enabled by:• Genomics, High Throughput Molecular Science• Ubiquitous data communications & computing
• Driven by National Programs:• Precision Medicine and Knowledge Networks• NIH / NCI Roadmaps• Translational & Biomarker Discovery Programs like
SPORE’s and SPECS• BD2K
TIME
UNDERSTANDING OF DISEASES
TRANSLATIONAL RESEARCH
MANAGEMENTOFPATIENTS
INF
OR
MA
TIO
NAccelerating Personalization of Care
Challenge: Filling in the Gap
• Bridge the lab and clinic in both directions
• Accelerate development of individual targeted agentsSmall moleculesAntibodiessiRNAs
• Accelerate development of individual biomarkersRiskTumor BurdenPredictive markers for response
• Integration of Genomics, Molecular Diagnostics and Therapeutics• Collaboration of Multiple Groups
•Academia, NIH/NCI, FDA, Pharma, Technology Partners
• Establish Translational Support Teams and Infrastructure
• Platform of common Informatics tools and Infrastructure• Standards – Its all about this – really !• Sustained Architecture• Systems Interoperability and Data Integration
Landscape: “…multiple collaborating investigators working as an investigative team in order to address complex
biomedical science problems…”
Leveraging Integrative Informatics Standards & Platforms to Enable High-throughput
Translational Research
Infrastructure for Collection, Management, Preservation, and Rapid Analysis of Clinical, Biomedical, and Biospecimen data under compliant conditions
MissionDeliver Suite of Services to support translational,
biomedical, and clinical research, as well as clinical care improvement.
FocusDevelopment of Systems and Infrastructure for the
- Capture, Storage, Dissemination of Clinical, Biomedical, and Research Data that can easily be merged, integrated, or aggregated
with other data sets.
- Integration of unified technology platforms leveraging cutting-edge advances in Informatics and computing.
• Identify and prioritize informatics needs in consultation with Faculty and Staff
• Evaluate alternative software and sometimes hardware approaches and implement the selected solutions, with the goal of building an advanced integrated informatics environment
• Assure compliance with governance, quality control, data privacy, and security standards for all informatics efforts.
• Oversee adoption of related national policies, guidelines and standards for clinical and biomedical data / metadata
• Provide consultation to facilitate use of specialized database software and bioinformatics tools
• Develop and implement customized software and research databases
• Data : Security, Compliance, Sharing, Governance• Relationship as appropriate with Vendor Community• Provide Biomedical Informatics systems and expertise in
support of grants, projects, and the preparation of manuscripts
•Provide Data Consultation and Research Design•Clinical / Biomedical Research Infrastructure•Clinical Research Informatics•Decision Support Service Infrastructure•Biospecimen / Tissue Informatics•Biomedical Informatics•High Performance Computing•Data Management and Integration•Data Marts & Data Mining•Informatics Education & Domain Expertise
1212
Centralized Research Data Management & Coordination
TI TI
Program SupportServices
Quality Control
Integration
Adoption
QualityAssurance
Training
• Infrastructure : Data Coordinating Center
• Clinical Research Informatics: Robust Clinical Data Capture & Trials Management System: OnCore EDC and CTMS (Lindsey Watt Alami Presentation Later Today)
• Clinical Registries (URM, REDCap)
• Biospecimen Informatics (BSM, STARS, LabVantage*)
• Patient Reported Outcomes (VissionTree)
• Federated Electronic Data Marts
• Business Intelligence Framework and Sophisticated Reporting
• Integration and Interoperability : CHR iRIS, APeX, Radiology
• NLP Methods and Tools
• HPC and BIG Data : High Performance Compute Resource: TIPCC (Richard Johnston @ Genius Booth)
• OnCore Help-Desk• Facilitate, Centralize, and Standardize Clinical Trial
Research Data Collection• Example: Completion of Protocol Registration Form
and submission • Example: Creating and Managing creation of all
Patient Study Calendars and CRF’s• Reporting and Data Extraction and Integration• Study information portal linkage locally and for Public• Continued Training and Hands On Support• Continued Data Quality Control and Auditing
Total Protocols : 4171 Total Active Protocols : 1682 Total Protocol Documents : 31,695 Total SAE’s : 2646 Total Subjects : 28,028 Active Users: 923
Protocols added in last 12 months: 446 222 oncology 224 non-oncology
*As of April 2014 – UCSF Wide
• Phase I : HL7 Live Data Feeds• APeX Patient Demographics • APeX LABS
• Phase II: • APeX RPE, • APeX Billing Grid
Demographics (HL7 ADT: APeX > OnCore)
Push subject demographics information from EMR
Laboratory (HL7 ORU: APeX > OnCore)
Populate OnCore eCRFs with lab results from lab system
Protocol Setup (RPE) (OnCore > APeX)
Sets Up Study Subjects in APeX: Information from OnCore is pushed to Epic to ‘flag’ subjects on a research study in OnCore:
Protocol Billing Grid (OnCore > APeX)
Provides an EMR with relative time points of a research study calendar including codes, billing designations and modifiers for assigned charge events & items.
Purpose is to support billing compliance.
Patient Demographics (Completed)
Fundamental Building Block of Integration APeX Pushing Patient Demographic Data: i.e.
• MRN• Name• Race• Ethnicity• Gender• Date of Birth• Address• Phone Number
Ensures the MRN from the EMR is the SAME primary research subject identifier: CRITICAL to the remaining, more advanced layers of integration
Additional Interoperability Projects
• CHR’s iRIS iMedRIS Phase I :
o iRIS > OnCore (in Progress)o iRIS Reporting via iMolytics Analytics
Phase II : OnCore > iRIS (under planning)
• Radiology > OnCore (under planning)• KBase / PMP Project (under discussion)• VissionTree P.R.O (under discussion)
• coPath Pathology Reports• coPath > OnCore BSM > Via i2e NLP Engine
Natural Language Processing: From Text to Meaning
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Transform Text into Insights
Turn text
Into structured datausing sophisticated queries
To driveanalytics
APeX
Cancer
Registry
OnCore
Biobank
Discussion