Standardisation of Trial Design Definitions in CDW
Nordic CDISC User Group meetingCopenhagen 22-April-2008
Mikkel Traun
Standardisation ofTrial Design Definitionsin CDW at Novo Nordisk
Standardisation of Trial Design Definitions in CDW Slide no 2
Agenda
Trial Design in context of CDW at Novo Nordisk1
CDISC SDTM Trial Design Model2
Trial Design metadata in CDW4
Standardised Protocol Trial metadata3
SDTM submission dataset from CDW5
First with Superior TherapiesR&D Vision
To be recognised as world leaders in drug development
Key Goal
Lets start with the Novo Nordisk R&D Vision
Reduce overall time to marketReduce overall time to market
Support increased number of projects
Support increased number of projects
Reduce late phase pipeline
attrition
Reduce late phase pipeline
attrition
Valu
e D
rivers
Reduce overall costs
Reduce overall costs
Support market launch
Support market launch
Support larger increase in
patient volumes
Utilize resources more efficientlyUtilize resources more efficiently
Leverage data better
Leverage data better
Cri
tica
l Succ
ess
Fact
ors
eClinical
Standardisation of Trial Design Definitions in CDW Slide no 4
By building the Clinical Data Warehouse (CDW) we will help Global Development reach its vision
Research Product Launch
Clinical Data
Stream-lined processes and tools for statistical analysis and clinical interpretation
F1rst with superior therapies
Improved decision making based on better utilisation of our accumulated data and knowledge
Shortened time to market
CDW
The CDW system is a means to reach the vision of Global Development and obtain the benefits
Cross-organisational clinical data warehouse
Clinical Data and trial meta data model
Standardisation
Adequate process changes
Standard program
catalogue
Access to historic
clinical data for analyses
Standardised global platform for statistical analysis and reporting
Allowing access to historic clinical data for explorative analyses
Establishing common standard clinical data model
Creation of trial design meta data standards
Development of a validated standard program catalogue for use in EOT documents
Frontloading and use of standards
Foundation for the solution
Standardisation of Trial Design Definitions in CDW Slide no 6
The benefits to be obtained with CDW
Compliance with federal regulations and NN procedures - globally
3
Increasing capacity of existing statistical staff
1
Ease the integration of data in clinical summaries and leveraged use of historic data
6
Reduction in critical time
path for statistical
analysis
2
Expansion of statistical
knowledge and capabilities
4
Globalization and knowledge sharing of clinical data
5
2008
2009
2010
Standardisation of Trial Design Definitions in CDW Slide no 7
Agenda
Trial Design in context of CDW at Novo Nordisk1
CDISC SDTM Trial Design Model2
Trial Design metadata in CDW4
Standardised Protocol Trial metadata3
SDTM submission dataset from CDW5
Standardisation of Trial Design Definitions in CDW Slide no 8
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)
Standardisation of Trial Design Definitions in CDW Slide no 9
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)
Standardisation of Trial Design Definitions in CDW Slide no 10
CDISC SDTM Trial DesignTrial Elements, Arms, Visits
Standardisation of Trial Design Definitions in CDW Slide no 11
Agenda
Trial Design in context of CDW at Novo Nordisk1
CDISC SDTM Trial Design Model2
Trial Design metadata in CDW4
Standardised Protocol Trial metadata3
SDTM submission dataset from CDW5
Standardisation of Trial Design Definitions in CDW Slide no 12
The CDW system- Standardisation is the foundation!
Cross-organisational clinical data warehouse
Clinical Data and trial meta
data model
Standardisation
Adequate process changes
Standard program
catalogue
Access to historic
clinical data for analyses
Standardisation of Trial Design Definitions in CDW Slide no 13
The Clinical Data Warehouse affects the data analysis and reporting process
Conduct
Analysis
Prepare
submission
Transfer
DataInitiate Trial
Set-up
Metadata
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
Standardisation of Trial Design Definitions in CDW Slide no 14
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
Standardisation of Trial Design Definitions in CDW Slide no 15
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
Standardisation of Trial Design Definitions in CDW Slide no 16
How to define and enter protocol metadata
Standardisation of Trial Design Definitions in CDW Slide no 17
How to define and enter protocol metadata
Standardisation of Trial Design Definitions in CDW Slide no 18
Definition of Visit structure
Standardisation of Trial Design Definitions in CDW Slide no 19
Definition of Visit structure
Standardisation of Trial Design Definitions in CDW Slide no 20
Definition of Visit structure
Standardisation of Trial Design Definitions in CDW Slide no 21
Description of trial design
Standardisation of Trial Design Definitions in CDW Slide no 22
Description of trial design
Standardisation of Trial Design Definitions in CDW Slide no 23
Standardisation of Trial Design Definitions in CDW Slide no 24
Trial design diagram
Standardisation of Trial Design Definitions in CDW Slide no 25
Trial products
Standardisation of Trial Design Definitions in CDW Slide no 26
Trial products
Standardisation of Trial Design Definitions in CDW Slide no 27
Trial products
Standardisation of Trial Design Definitions in CDW Slide no 28
Dosage
Standardisation of Trial Design Definitions in CDW Slide no 29
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
Standardisation of Trial Design Definitions in CDW Slide no 30
Agenda
Trial Design in context of CDW at Novo Nordisk1
CDISC SDTM Trial Design Model2
Trial Design metadata in CDW4
Standardised Protocol Trial metadata3
SDTM submission dataset from CDW5
Standardisation of Trial Design Definitions in CDW Slide no 31
• 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)
Create Generic Trial Design 1Case 3:
Standardisation of Trial Design Definitions in CDW Slide no 32
Create Generic Trial Design 2Case 3:
• Illustrating Element, Arm, Visit
Standardisation of Trial Design Definitions in CDW Slide no 33
Create Generic Trial Design 7Case 3:
• Generic Trial Design as defined in CDW-Operations
Standardisation of Trial Design Definitions in CDW Slide no 34
Create Generic Trial Design 8Case 3:
• Trial Design defined in CDW-O with protocol attributes
Standardisation of Trial Design Definitions in CDW Slide no 35
Trial Design datasets in CDW SCEPlanned Trial Arm
Standardisation of Trial Design Definitions in CDW Slide no 36
Trial Design datasets in CDW SCEPlanned Trial Element
Standardisation of Trial Design Definitions in CDW Slide no 37
Trial Design datasets in CDW SCEPlanned Trial Epoch
Standardisation of Trial Design Definitions in CDW Slide no 38
Trial Design datasets in CDW SCEPlanned Trial Design Matrix Cell
Standardisation of Trial Design Definitions in CDW Slide no 39
Agenda
Trial Design in context of CDW at Novo Nordisk1
CDISC SDTM Trial Design Model2
Trial Design metadata in CDW4
Standardised Protocol Trial metadata3
SDTM submission dataset from CDW5
Standardisation of Trial Design Definitions in CDW Slide no 40
Data Flow
OC Clinical dataOC Metadata
MedDRA
OC Clinical dataOC Metadata
MedDRA
Trial MetadataTrial Metadata
MDRMDR
NN CDMS
IMPACT
CDW Operations
SDM
MMA
Admin
Source Systems Data Processing Analysis & Reporting
StagingStaging
CDR CDR
Statistical Computing Environment
ADMADM
DDM
ADS
Tab
les, L
istin
gs, F
igu
res,
Su
bm
issio
n d
ata
sets
Sta
tistic
al D
ocu
men
tatio
n
Metadata driven data flow
Standardisation of Trial Design Definitions in CDW Slide no 41
SDTM Trial Arm dataset
Standardisation of Trial Design Definitions in CDW Slide no 42
Query for SDTM Trial Arm dataset
Standardisation of Trial Design Definitions in CDW Slide no 43
SDTM Trail Arm dataset
Standardisation of Trial Design Definitions in CDW Slide no 44
The trial meta data - brings us a number of benefits
Data handling
Data handling
Statistical Analysis
Statistical Analysis ReportingReporting
Metadata driven mapping and enrichment of study data
Matching analysis methods to study design
Metadata driven reports and output management
In order to make use of the data in the CDW, the trial metadata need to be standardised
Data
PreparationReporting
Today Tomorrow with CDW
Data Preparation
Reporting
• Programming code reusability• Integration of data into standardised structure• Data preparation & reporting optimisation• Frontloading
Standardisation of Trial Design Definitions in CDW Slide no 45
…next
• Questions
• How do you plan to manage Trial Design metadata
Top Related