Seamless Dataflow with a Clinical Metadata Repository
Download as PPTX, PDF1 like1,779 views
Parexel International discusses the importance of a clinical metadata repository (MDR) to address issues like data interpretation discrepancies, linear progression in data management, and misalignment with standards in clinical studies. By implementing a hub and spokes model, the MDR improves data integration, consistency, and quality, enabling better study execution aligned with governance processes. This approach aims to streamline clinical data handling, enhancing overall study timelines and quality.
Seamless Dataflow with a Clinical Metadata Repository
- 1. © 2017 PAREXEL INTERNATIONAL CORP. SEAMLESS DATAFLOW WITH A CLINICAL METADATA REPOSITORY September 27th 2017, La Jolla, CA Julius Kusserow
- 2. © 2017 PAREXEL INTERNATIONAL CORP. / 2 AGENDA • Problems we observe • Hub & spoke model – to connect the data • Study instance metadata – to have a machine readable protocol • The metadata repository (MDR) – to bring it all together • Having all together - Benefits for using the PAREXEL Clinical MDR to Manage Metadata on Studies
- 3. © 2017 PAREXEL INTERNATIONAL CORP. / 3 ABOUT PAREXEL • A leading global biopharmaceutical services organization • 30+ years assisting clients in pharmaceutical, biotechnology, and medical device industries • We are physicians, technologists, business process experts, and more WE ARE A TEAM OF EXPERTS DEDICATED TO YOUR JOURNEY TO MARKET.
- 4. © 2017 PAREXEL INTERNATIONAL CORP. / 4 WHAT WE OFFER PAREXEL is focused on end-to-end integrated solutions – from product strategy and clinical development through market access and lifecycle management. We simplify the journey between science and new treatments by applying: BEST MINDS PROBLEM-SOLVINGINNOVATION
- 5. © 2017 PAREXEL INTERNATIONAL CORP. / 5 PROBLEM 1: DIFFERENT INTERPRETATIONS OF THE SAME PROTOCOL • Different interpretations of protocol • Need for data reconciliation • Time to build integrated SDTM data sets, ADaM & TLFs
- 6. © 2017 PAREXEL INTERNATIONAL CORP. / 6 PROBLEM 2: LINEAR BUILD - “WALKING THE LINE“ We work in a linear way… with circles ANALYZE Tabulation data needs to be available before the analysis datasets are created Comment TABULATE Data needs to be entered before we can produce tabulation data (SDTM) Wait Comment BUILD We need to build a database before we can enter data Wait
- 7. © 2017 PAREXEL INTERNATIONAL CORP. / 7 PROBLEM 3: MISALIGNMENT OF STUDIES TO STANDARDS Standard Study 1 Study 2 Study 3≠ ≠ • Studies follow standard on a structure level, but diverge on the implementation of variable content which could lead to different semantics. • Harmonization costs additional time.
- 8. © 2017 PAREXEL INTERNATIONAL CORP. / 8 HUB AND SPOKES LIFECYCLE MANAGEMENT OFDATA STANDARDS LIBRARYOF SIM STUDY INSTANCE METADATA PAREXELCLINICALMDR Same things in the real world are represented by a concept. The pattern allows a logical association between: • one Domain Definition Variable in the Hub, representing a concept • and different Spoke Variables, representing different expressions of the concept
- 9. © 2017 PAREXEL INTERNATIONAL CORP. / 9 … IN AN EXAMPLE • Mapping by declaration to concepts • Allows End to End (E2E) data flow dry-run without data • Study teams worry about the what not the how • ISO 21090 BASED CLINICAL RECOGNIZABLE CONCEPTS • DATA IS MAPPED TO AND FROM A HUB • USABLE FOR CDISC AND OTHER DATA MODELS (HUB) CDASH / Data Collection AESEV Severity SDTM / Data Tabulation AESEV Severity/Intensity (SPOKES) AE Domain Definition Pattern Ordinal Coded Item Concept SEV Severity/Intensity ADaM / Data Analysis AESEV Severity/Intensity AESEVN Severity/Intensity (N) ASEV Analysis Severity/Intensity ASEVN Analysis Severity/Intensity (N) SEVGRy Pooled Severity Group y SEVGRyN Pooled Severity Group y (N)
- 10. © 2017 PAREXEL INTERNATIONAL CORP. / 10 …IN THE FUTURE LIFECYCLE MANAGEMENT OFDATA STANDARDS LIBRARYOF SIM STUDY INSTANCE METADATA PAREXELCLINICALMDR The pattern can be extended (if needed) to allow a logical association of already defined Domain Definition Variables to new Spokes
- 11. © 2017 PAREXEL INTERNATIONAL CORP. / 11 STUDY INSTANCE METADATA - THE MACHINE READABLE PROTOCOL Common Process • Different interpretations of protocol • Need for data reconciliation • Time to build integrated SDTM data sets, ADaM & TLFs 3 Tier approach with MDR & SCE • One single interpretation of protocol • Increased consistency and data quality • Reduced time for integration
- 12. © 2017 PAREXEL INTERNATIONAL CORP. / 12 MANAGEMENT OF DATA STANDARDS THE METADATA REPOSITORY PAREXELCLINICALMDR HUB & SPOKES EDC IVRS ePRO Lab Macro Library Statistical Computing Environment Data Surveillance Protocol Optimization Clinical Data Repository MANAGEMENT OF STUDY INSTANCE METADATA Study Design (SDTM TDM) Visit Schedule with T&E HUB & SPOKES
- 13. © 2017 PAREXEL INTERNATIONAL CORP. / 13 • Hub and spokes model bridged all cracks between the different department standards • Development of concepts and pattern is a cross functional effort The MDR is necessary to: • Maintain all the metadata on a standard level • Give study team the tools to handle the metadata • Study teams see impact on down the line activities during planning • Study Instance Metadata (SIM) brought study execution closer to standards governance DATA BRINGING IT ALL TOGETHER TECHNOLOGYORGANIZATION PAREXEL CLINICAL MDR Enabling MDR Technology Underpinning by Hub, Spokes, Concepts & Pattern Aligned Governance Processes
- 14. © 2017 PAREXEL INTERNATIONAL CORP. / 14 • Each setup along the line is aware of upstream & downstream impact. • Concepts allow to focus on the content and avoid common traps. • Study related standards governance reduced • Metadata driven mapping • Better setup • Ability to have mappings earlier BENEFITS QUALITY EFFORTSTUDY TIMELINES
- 15. © 2017 PAREXEL INTERNATIONAL CORP. / 15 THANK YOU © 2017 PAREXEL INTERNATIONAL CORP. / 15
Editor's Notes
- #4: PAREXEL is a global biopharmaceutical services company focused on end-to-end integrated solutions – from product strategy and clinical development through market access and lifecycle management.
- #8: Always treat values together value and unit -> unit means nothing without a value Which weight use for BMI ( different BL flags in SDTM & ADaM) BMI at study start vs. BMI at treatment start