Standardisation of Trial Design Definitions in CDW Nordic CDISC User Group meeting Copenhagen 22-April-2008 Mikkel Traun Standardisation of Trial Design

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


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


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


Agenda







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)


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)


CDISC SDTM Trial DesignTrial Elements, Arms, Visits


Agenda







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


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


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


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






Definition of Visit structure






Description of trial design


Description of trial design



Trial design diagram


Trial products


Trial products


Trial products


Dosage


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


Agenda







• 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:



• Illustrating Element, Arm, Visit



• Generic Trial Design as defined in CDW-Operations



• Trial Design defined in CDW-O with protocol attributes


Trial Design datasets in CDW SCEPlanned Trial Arm


Trial Design datasets in CDW SCEPlanned Trial Element


Trial Design datasets in CDW SCEPlanned Trial Epoch


Trial Design datasets in CDW SCEPlanned Trial Design Matrix Cell


Agenda







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


SDTM Trial Arm dataset


Query for SDTM Trial Arm dataset


SDTM Trail Arm dataset


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


…next

• Questions

• How do you plan to manage Trial Design metadata

Documents

Standardisation of Trial Design Definitions in CDW Nordic CDISC User Group meeting Copenhagen 22-April-2008 Mikkel Traun Standardisation of Trial Design