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Standardisation of Trial Design Definitions in CDW at Novo Nordisk

Standardisation of Trial Design Definitions in CDW at Novo Nordisk. Nordic CDISC User Group meeting Copenhagen 22-April-2008 Mikkel Traun. CDISC SDTM Trial Design Model. Trial Design metadata in CDW. Standardised Protocol Trial metadata. SDTM submission dataset from CDW. 2. 4. 3. 5.

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Standardisation of Trial Design Definitions in CDW at Novo Nordisk

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  1. Standardisation of Trial Design Definitions in CDW Standardisation ofTrial Design Definitionsin CDW at Novo Nordisk Nordic CDISC User Group meeting Copenhagen 22-April-2008 Mikkel Traun

  2. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model Trial Design metadata in CDW Standardised Protocol Trial metadata SDTM submission dataset from CDW 2 4 3 5 Trial Design in context of CDW at Novo Nordisk 1 Agenda

  3. R&D Vision First with Superior Therapies Key Goal To be recognised as world leaders in drug development Support increased number of projects Reduce late phase pipeline attrition Reduce overall time to market Reduce overall costs Support market launch Value Drivers Support larger increase in patient volumes Utilize resources more efficiently Leverage data better Critical Success Factors Lets start with the Novo Nordisk R&D Vision eClinical

  4. Standardisation of Trial Design Definitions in CDW By building the Clinical Data Warehouse (CDW) we will help Global Development reach its vision F1rst with superior therapies Shortened time to market Research Product Launch Clinical Data Improved decision making based on better utilisation of our accumulated data and knowledge Stream-lined processes and tools for statistical analysis and clinical interpretation CDW

  5. The CDW system is a means to reach the vision of Global Development and obtain the benefits Foundation for the solution Standardised global platform for statistical analysis and reporting Establishing common standard clinical data model Creation of trial design meta data standards Cross-organisational clinical data warehouse Frontloading and use of standards Clinical Data and trial meta data model Standard program catalogue Access to historic clinical data for analyses Adequate process changes Standardisation Development of a validated standard program catalogue for use in EOT documents Allowing access to historic clinical data for explorative analyses

  6. Standardisation of Trial Design Definitions in CDW Compliance with federal regulations and NN procedures - globally Increasing capacity of existing statistical staff Globalization and knowledge sharing of clinical data 5 3 1 2010 2009 Ease the integration of data in clinical summaries and leveraged use of historic data Reduction in critical time path for statistical analysis Expansion of statistical knowledge and capabilities 2 4 6 2008 The benefits to be obtained with CDW

  7. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model Trial Design metadata in CDW Standardised Protocol Trial metadata SDTM submission dataset from CDW 2 4 3 5 Trial Design in context of CDW at Novo Nordisk 1 Agenda

  8. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model • Purpose is to support reviewer to: • Clearly and quickly grasp the design of a clinical trial • Compare the designs of different trials • Search a data warehouse for clinical trials with certain features • Compare planned and actual treatments and visits for subjects in a clinical trial (future)

  9. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design datasets • Trial Arms (Planned) • Trial Elements (Planned) • Trial Visits (Planned) • Trial Inclusion/Exclusion Criteria (Lookup table) • Trial Summary (Descriptive attributes of trial)

  10. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial DesignTrial Elements, Arms, Visits

  11. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model Trial Design metadata in CDW Standardised Protocol Trial metadata SDTM submission dataset from CDW 2 4 3 5 Trial Design in context of CDW at Novo Nordisk 1 Agenda

  12. Standardisation of Trial Design Definitions in CDW The CDW system- Standardisation is the foundation! Cross-organisational clinical data warehouse Clinical Data and trial meta data model Standard program catalogue Access to historic clinical data for analyses Adequate process changes Standardisation

  13. Standardisation of Trial Design Definitions in CDW The Clinical Data Warehouse affects the data analysis and reporting process Initiate Trial Set-up Metadata Transfer Data Conduct Analysis Prepare submission Request for Trial Definition and Trial Container Use metadata standards from protocol onwards Access request for Trial Definition and Trial Container Metadata set-up is mandatory Protocol and statistical metadata mainly entered through applications a few transferred from Source System Mapping of transfer from OC to CDW Data Enrich-ments in transfer from OC to CDW Use of standard programs from standard library Standardised framework for making derived datasets Metadata ADM contains reference of the metadata for trials available in CDW to use for searches Storage of data to facilitate SDTM data submission

  14. Standardisation of Trial Design Definitions in CDW Protocol information (metadata) to include in CDW • Title – free text • Objectives – free text • End-points – free text • Visit structure – template • Description of trial design – code lists • Trial design diagram – template • Trial products – template • Dosage - template • Trial flow chart – template • Sampling profile - template

  15. Standardisation of Trial Design Definitions in CDW How to define and enter protocol metadata • Templates have been created in Excel worksheets • Standard definitions and terminology has been agreed and code lists created • Standard terms are to be selected from drop down lists in the templates • Code lists will be updated on a regular basis when requested

  16. Standardisation of Trial Design Definitions in CDW How to define and enter protocol metadata

  17. Standardisation of Trial Design Definitions in CDW How to define and enter protocol metadata

  18. Standardisation of Trial Design Definitions in CDW Definition of Visit structure

  19. Standardisation of Trial Design Definitions in CDW Definition of Visit structure

  20. Standardisation of Trial Design Definitions in CDW Definition of Visit structure

  21. Standardisation of Trial Design Definitions in CDW Description of trial design

  22. Standardisation of Trial Design Definitions in CDW Description of trial design

  23. Standardisation of Trial Design Definitions in CDW

  24. Standardisation of Trial Design Definitions in CDW Trial design diagram

  25. Standardisation of Trial Design Definitions in CDW Trial products

  26. Standardisation of Trial Design Definitions in CDW Trial products

  27. Standardisation of Trial Design Definitions in CDW Trial products

  28. Standardisation of Trial Design Definitions in CDW Dosage

  29. Standardisation of Trial Design Definitions in CDW How to use the templates • When a new protocol is being created the templates must be used to secure that protocol metadata are defined in a standardised way. • After completion the excel worksheets, these are exported to a ’Protocol metadata document’ • This ’Protocol metadata document’, are separate sheets that will follow the protocol and which will be filed in NovoDocs • The protocol originator may choose to include completed templates or part of these in the protocol text • Use of protocol standards will be included in the QC check of protocol before PRC submission

  30. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model Trial Design metadata in CDW Standardised Protocol Trial metadata SDTM submission dataset from CDW 2 4 3 5 Trial Design in context of CDW at Novo Nordisk 1 Agenda

  31. Standardisation of Trial Design Definitions in CDW Case 3: Create Generic Trial Design 1 • What is generic trial design • A template of a Trial Design, where the type and relationship between arms, branches, epochs and elements are defined. • The generic trial design template facilitate a standardised definition of trial design that supports the generation of trial design submission datasets and can be used by standard programs. • Terminology (arms, branches, epochs, elements)

  32. Standardisation of Trial Design Definitions in CDW Case 3: Create Generic Trial Design 2 • Illustrating Element, Arm, Visit

  33. Standardisation of Trial Design Definitions in CDW Case 3: Create Generic Trial Design 7 • Generic Trial Design as defined in CDW-Operations

  34. Standardisation of Trial Design Definitions in CDW Case 3: Create Generic Trial Design 8 • Trial Design defined in CDW-O with protocol attributes

  35. Standardisation of Trial Design Definitions in CDW Trial Design datasets in CDW SCEPlanned Trial Arm

  36. Standardisation of Trial Design Definitions in CDW Trial Design datasets in CDW SCEPlanned Trial Element

  37. Standardisation of Trial Design Definitions in CDW Trial Design datasets in CDW SCEPlanned Trial Epoch

  38. Standardisation of Trial Design Definitions in CDW Trial Design datasets in CDW SCEPlanned Trial Design Matrix Cell

  39. Standardisation of Trial Design Definitions in CDW CDISC SDTM Trial Design Model Trial Design metadata in CDW Standardised Protocol Trial metadata SDTM submission dataset from CDW 2 4 3 5 Trial Design in context of CDW at Novo Nordisk 1 Agenda

  40. Standardisation of Trial Design Definitions in CDW Data Flow Source Systems Data Processing Analysis & Reporting NN CDMS Statistical Computing Environment OC Clinical data OC Metadata MedDRA Staging ADS IMPACT DDM Trial Metadata Tables, Listings, Figures, Submission datasets Statistical Documentation CDW Operations CDR ADM Admin MDR SDM MMA Metadata driven data flow

  41. Standardisation of Trial Design Definitions in CDW SDTM Trial Arm dataset

  42. Standardisation of Trial Design Definitions in CDW Query for SDTM Trial Arm dataset

  43. Standardisation of Trial Design Definitions in CDW SDTM Trail Arm dataset

  44. Standardisation of Trial Design Definitions in CDW The trial meta data - brings us a number of benefits • Programming code reusability • Integration of data into standardised structure • Data preparation & reporting optimisation • Frontloading Data handling Statistical Analysis Reporting In order to make use of the data in the CDW, the trial metadata need to be standardised Metadata driven mapping and enrichment of study data Matching analysis methods to study design Metadata driven reports and output management Today Tomorrow with CDW Data Preparation Reporting Data Preparation Reporting

  45. Standardisation of Trial Design Definitions in CDW …next • Questions • How do you plan to manage Trial Design metadata

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