CDISC & HL7 Moving the Clinical Research Agenda …...The Fundamentals of FHIR • A next generation...
Transcript of CDISC & HL7 Moving the Clinical Research Agenda …...The Fundamentals of FHIR • A next generation...
CDISC & HL7 Moving the Clinical Research Agenda Forward
CDISC & HL7 Moving the Clinical Research Agenda Forward
Sam Hume, CDISC
Wayne Kubick, HL7
Speaker Introduction
Wayne R. Kubick, BA, MBA
Chief Technology OfficerHealth Level Seven International@WayneKubick
Sr. Executive with more than 25 years of experience in pharmaceutical clinical research processes, standards and technologies.
Former CTO, CDISC
Speaker Introduction
Sam Hume, D.Sc.
Head of Data Exchange TechnologiesClinical Data Interchange Standards Consortium@swhume
I specialize in clinical research and healthcare informatics including data exchange, data integration, software development, and related research projects.
About Health Leven 7 International• ANSI-accredited healthcare standards development organization with
>2500 members in more than 55 countries
– >300 standards products
– Major product families: v2, v3, CDA, FHIR
– Regulated Research products: SPL, ICSR, IDMP
• HL7 Vision: A world in which everyone can securely access and use the right health data when and where they need it
• HL7 Mission: To provide standards that empower global health data interoperability www.hl7.org
The Fundamentals of FHIR
• A next generation standards framework & platform, built on 30 years of HL7 experience, designed for implementation
• Based on REST, a pattern for using web technologies to manage information (the platform used by Facebook, Twitter…) and APIs
• Content based on Resources: essential, portable modular information components easily assembled into working systems
• - Like web pages directed toward computers; fast and scalable
• Flexible outputs: web, messages, documents, servicesREST
Documents
Messages Services
FHIR
Resources
Smallest logically discrete units
of “transaction of interest” to
healthcare
US Core Data for Interoperability (USCDI) & Trusted Exchange Framework
https://www.healthit.gov/sites/default/files/draft-uscdi.pdf
EHRFHIR
API
Feasibility, Investigator & Subject Searches
CDA
Archive
Copy
Pre-populate EDC CRFs
Drilldown analysis of source data by
regulatory reviewers
Bulk transfer of clinical data for analytics
Monitor Protocol Execution
Collect Patient-Originated Data; eConsent
Apply Data Corrections simultaneously to
EHR & EDC
Drive pragmatic trials and precision
medicine
How HL7 FHIR Can Improve Biomedical Research
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Global Standards Development Organization (SDO)
Founded in 1997 (all volunteers)
>440 organizational members
Standards for clinical & translational research
Mission: To develop and support global, platform-independent data
standards that enable information system interoperability to improve
medical research and related areas of healthcare
Clinical Data Interchange Standards Consortium
Support Common Functions for All Research
Data Collection
Providing Common Structure & Terminology for:
Data Aggregation
(Tabulation)
Data Analysis Data Transfer
CDISC Standards Cover the Full Clinical & Translational Lifecycle
ODM v2 & CDISC SHAREModern, extensible data transport & sharing standard supporting software
innovation, process automation & interoperability among enterprise systems.
End to End
Standards
CDISC SHARE
Aligning CDISC Models with RWD RWE
RWD RWEDecision Support
CDISC is:
• Working to connect EHRs to CDASH using FHIR
• Building connected views of data that align with RWD
• Developing terminology for ePRO
• Continuing to support registries and pragmatic trials
Pre-populating Case Report Form Data
CDISC is:
• Extending CDASH and ODM to represent metadata that maps EHR data to
CDASH CRFs using FHIR resources
• Maintaining the FHIR to CDASH mapping metadata in the CDISC SHARE MDR
• Developing a standard ODMv2 API to pre-populate CRFs across EDC systems
Some Talking Points• Digital health data, which is becoming more accessible, consistent and
reliable under 21st Century Cures through FHIR APIs, can provide significant benefits for Biopharma research
• Research would benefit by learning how to use data in its original form as represented via FHIR resources, minimizing transformations, terminology conversions and mapping
• CDISC standards such as CDASH and SDTM are still significant, and required for the near future for regulatory submissions, but can also likely be adapted as views on FHIR resources in the future.
• The vast power, potential and widespread acceptance of the FHIR platform standard will likely catalyze many new opportunities to improve healthcare treatment and outcomes.
CDISC & HL7 Moving the Clinical Research Agenda Forward
Sam Hume, CDISC
Wayne Kubick, HL7