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Designing and launching the Clinical Reference Library
 

Designing and launching the Clinical Reference Library

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Presentation for the European Clinical Data Forum conference, 24 May, 2011. Describing the business problems and drivers behind the design of a ISO11179 based metadata registry for clinical data. And ...

Presentation for the European Clinical Data Forum conference, 24 May, 2011. Describing the business problems and drivers behind the design of a ISO11179 based metadata registry for clinical data. And also introducing the features of the CRL application.

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    Designing and launching the Clinical Reference Library Designing and launching the Clinical Reference Library Presentation Transcript

    • Designing & Launching the Clinical Reference Library Kerstin Forsberg Mike Combs AstraZeneca R&D, Sweden IBM Global Clinical Information Strategy Pharmaceutical Team [email_address] [email_address]
    • Business Problems
      • Multitude of competing and overlapping industry standards
        • Rapid growth through mergers and acquisitions
        • Partnering trend
        • Culturally and geographically dispersed teams collaborate less on trial design
        • Advances in basic science lead to new measures and tests
      • Even the standards that exist (e.g. SDTM for submission) allow for many variances – often referring to the same concept:
        • Choice of unit of measure
        • Choice of controlled terminology
        • Could be extended by a trial to support custom data elements
      The realities of clinical trials data – the variances, changes, diversity and gaps in clinical data
      • Diversity across regions, authorities, partners and tools
      • Lack of explicit clinical data
        • In many cases clinical data do not include information required to make it meaningful for reuse. Useful information is implied in study documents and embedded in variable names and labels
      • Evolving medical knowledge and clinical practice
      • Medical relevant diversity across disease areas and drug projects
      • Progression of clinical data through the life cycle
      Designing the Clinical Reference Library | European Clinical Data Forum Kerstin Forsberg | May 2011
    • Business Drivers The CRL designed for “Controlled Flexibility”
      • Anticipate diversity in clinical data as part of “doing research”
        • Business value achieved by effective use and re-use of clinical data cross studies and over time.
        • With CRL the variances, changes and diversity in clinical data can be specified and handled, and the gaps can be identified and filled.
      • Enforce one standard for operational efficiency
        • Operational efficiency achieved by rationalization of processes and tools.
        • CRL support this by making the preferred (standardized) variant available as first option when setting up new studies.
      Designing the Clinical Reference Library | European Clinical Data Forum Kerstin Forsberg | May 2011
    • Business Problems
      • Statisticians spend their time doing statistics and not data searching, integration, manipulation and conforming
      • Information is made available to a wider audience in clinical development enabling the evaluation of more hypotheses
      • Cost of doing business is significantly reduced
      • Increased value through increased effort spent on analysis and report writing
      Huge effort is wasted in data integration because of the data differences and the lack of an automated transformation mechanism Time Decision Analyze & Report Data % of total effort 0 100 0 100 Current Model Time Analyze & Report Data Decision % of total effort 0 100 0 100 Optimal Model Time Time Saving Value Designing the Clinical Reference Library | European Clinical Data Forum Kerstin Forsberg | May 2011 Gather Data Integrate Data Integrate Data
    • Business Drivers CRL was designed based on explorative work 2002-2007: CDISC standards, FDA Janus model, Metadata standards and tools, emerging ontologies for the clinical domain, software patterns, …
      • Manage evolving clinical trial data standards
      • Automate data transformations to prepare for submissions
      • Make clinical trial data comparable, both retrospectively (for existing studies) and prospectively (for new studies).
      Designing the Clinical Reference Library | European Clinical Data Forum Kerstin Forsberg | May 2011
    • Clinical Reference Library (CRL) CRL was designed to register, organize and classify clinical data items used within an organization
      • CRL is a repository for information (metadata) about clinical data items
      • This information is currently scattered across the organization in unstructured protocol documents, clinical systems, and experts’ knowledge
      • Storing this information in a structured repository would simplify cross-protocol data integration, promote standards’ adoption, improve re-usability, and enhance knowledge sharing
      Expert CDMS/EDC Protocol Designing the Clinical Reference Library | European Clinical Data Forum Kerstin Forsberg | May 2011
    • Data Warehouse Data Marts Observational Data Store Clinical Reference Library Standards Team maintain definitions in CRL Legacy Studies External Collaborators ODS provides a single data definition standard into which all new and historic data is loaded prior to extraction for various purposes Provides clear definition of ODS contents Provides electronic data definition to acquisitions applications With the use of Enrichment configurations observational data can be transformed to the standard Data Extraction Configurations help automate extraction to a required configuration Data Extract Data Extract Data Extraction Configurations help automate extraction to a required configuration. Multiple configurations can be held in CRL to allow for different extracts such as SDTM for FDA and CDISC ODM for transfer to a partner Loading of data checked using data acquisition configuration Clinical Studies CRL Drives the Automated Capture & Transformation of Data Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • How CRL can help
      • Study Meta Data can be transferred into CRL
      • CRL employs a process of matching to already present configurations for the data, or creating new ones if necessary
      • CRL is then able to export configuration data to control transformation programs to harmonize the study data
      • Configuration data contains structural information & lexography used in harmonising data entities
      • Study data can then be used for pooling, cross study analysis or analysis by Business Intelligence Tools
      Use of CRL to Harmonize Data Sources in Combination with a Clinical Data Repository Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • CONCEPT: This layer describes medical concepts; the different methods of measuring and fully representing the concepts and their equivalences; relationships between concepts; and their classification CONFIGURATION: This layer specifies the different data items (defined in the concept layer) that are used for a particular clinical trial, project or standard STRUCTURE: This layer describes the structure of the datasets and variables for a particular clinical trial, project or standard CRL Conceptual Model CRL stores and manages 3 levels of metadata describing clinical data and their use within trials Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • CONCEPT: This layer describes medical concepts; the different methods of measuring and fully representing the concepts and their equivalences; relationships between concepts; and their classification CRL Conceptual Model The concept layer captures content in the library at the atomic level Observations - Real World Phenomenon - Observation Concept - Observation Type - Observation Qualifiers - Carrier of Topic - Classification Standards - Groups - Relationships Enrichment - Implicit Value - Uniformed Value Meaning Versions & Alternatives - Synonyms - Historical Linkage Data Element Concepts - Data Element Concept - Data Element - Conceptual Domain - Value Domain - Value Meaning - Unit of Measure - Permissible Value Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • CRL Conceptual Model The configuration layer is where content from the library is collected and made available to external applications Configuration Components - Property Type - Observation Type - Subject Type - Arm, Subject, Site - Relationship - Group - Transposed Structure - Data Structure Type - Implicit Specification Configurations - Represent Existing Data - Extracts - Data Acquisition - Enrichments CONFIGURATION: This layer specifies the different data items (defined in the concept layer) that are used for a particular clinical trial, project or standard Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • CRL Conceptual Model The structure layer defines the physical structure for variables and datasets within a study Data Structures Identifiers Transposed Structures STRUCTURE: This layer describes the structure of the datasets and variables for a particular clinical trial, project or standard Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential
    • CRL Has Been Built & Launched IBM has built and Launched version 1 of the CRL – offering the core components Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential