© CDISC 2015 1

CDISC Day – Milano

Europe CDISC Coordinating Committee (E3C)

CDISC Operations

CDISC Europe Foundation

30 September 2015

© CDISC 2015 2

Peter Van Reusel

Business & Decision Life Sciences

Bron Kisler

CDISC

Isabella Montagna

Chiesi Farmaceutici

(local CDISC implementation)

Paul Houston

CDISC

Introductions

Diana Harakeh

CDISC

Andrea Rauch

Boehringer Ingelheim

Jörg Dillert

Oracle

Mark LambrechtSAS

© CDISC 2015 3

E3C Update: The 14th Year

Peter Van ReuselChair, CDISC E3C

© CDISC 2015 4

E3C Charter• Purpose

Yearly action plan, aligned with CDISC Strategic Goals Organize & Promote CDISC Interchanges for Europe Liaise with regulatory authorities on behalf of CDISC Assess regional CDISC training needs Assist in the creation & coordination of European User

Networks Communicate activities

• Composed of volunteers Sponsors CRO Vendors Academia

• Represent Europe

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Annual MeetingsWorkshops

Frankfurt 2002 Dublin 2003

Interchanges Brussels 2004 Paris 2005 Berlin 2006 Montreux 2007 Copenhagen 2008 Budapest 2009 London 2010 Brussels 2011 Stockholm 2012 Frankfurt 2013 Paris 2014 Basel 2015 Vienna 2016

Paris

LondonBrussels

Dublin

Budapest

Stockholm

Copenhagen

Frankfurt

Berlin

Basel

Montreux

Vienna

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CDISC Europe InterchangeVienna, Austria – 25-29 April 2016

Become a Sponsor TodayPlace Your Logo on this Banner to be Displayed on the CDISC Website!

© CDISC 2015 7

Foundational Products Released in 2015:• SENDIG v3.1 Draft B• ADaM Occurrence Data Structure v1• ADaM Results Metadata Spec for Define-XML

2.0• ADaM Validation Checks v1.3• Pharmacogenomic SDTMIG v1• CDISC in RDF Reference Guide v1 Final

(PhUSE)• Periodic Terminology and COA Packages• Updated COP and Process Docs• SDTMIG 3.3 Draft• SDTM v1.5 Draft• ADaM v2.1 Draft

Upcoming New Drafts for Comment:• CDASH v2 and Model• ADaM Standards in Development / Future

Plans

Progress Update – Foundational Stds

© CDISC 2015 8

TA standards released in 2014-2015:• Multiple Sclerosis • Diabetes• Cardiovascular• Influenza• QT Studies• Chronic Hep-C• Schizophrenia• Dyslipidemia

Upcoming by Dec 2015:• Breast Cancer• Traumatic Brain Injury• COPD• Diabetes (ADaM Supplement)• Virology v2

© CDISC 2015

CFAST Pipeline

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Pre-CFAST 2012-2015 2015 2016Alzheimer’s v1 Asthma v1 Traumatic Brain

Injury v1 (One Mind Foundation)

Duchenne Muscular Dystrophy

Parkinson’s v1 Alzheimer’s v2 Oncology - Breast Oncology – Lung

Polycystic Kidney Disease v1 (PKD Foundation )

Multiple Sclerosis v1 (MS Society)

COPD Oncology – Colorectal (US FDA)

TB v1 (Gates) Diabetes v1 Virology v2 Osteoporosis

Virology v1 CV Endpoints v1 TB v2 (Gates) Malaria (Gates)

Influenza (FDA) Rheum. Arthritis Multiple Sclerosis v2 ?

Hepatitis-C (FDA) CV Imaging Post Traumatic Stress ?

Schizophrenia (US FDA)

Oncology – Prostate (FDA)

Parkinson’s v2 ?

Dyslipidemia Major Depression

General Anxiety Disorder

Biopolar

Projects in Bold have been completed / published

© CDISC 2015

SHARE Road Map: Incremental Implementation

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R1Q1 2014

R2Q4 2014

R3Q4 2015

R4Q4 2016

Major Versions: Releases 1 - 4

© CDISC 2015

R3: End-to-End Standards Model

• R1 Theme: Machine-Readable Standards

• R2 Theme: SHARE Concept Model

• R3 Theme: End-to-End Standards Model

• R4 Theme: Multiple Concept Systems

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R3Q4 2015

© CDISC 2015

SHARE and Therapeutic Area Standards Development

TA Standards Available:

• Asthma• Alzheimer's• Virology• Cardiovascular• Diabetes• Influenza• Dyslipidemia

Future: TA Standards

• Prostate Cancer development pilot

• Specification documents generated from SHARE

• Metadata CDASH, SDTM, & ADaM

• Examples• Biomedical Concepts• Diff files

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© CDISC 2015

Early Examples of Demonstrated Value

• "Before the variables of the SDTM-IG were published electronically in eSHARE, it took me all my evenings during two weeks to copy and paste the information from a new SDTM-IG into my SDTM-ETL mapping software. After the variables were published in eSHARE as a worksheet, it took me just 2 hours.”

• "Once CDISC publishes the variables of the SDTM-IG as a Define-XML template, it will take me 2 minutes."

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© CDISC 2015

SHARE API Program

• Programmatic access to SHARE content

• Targeted at vendors and MDR implementations Allows vendors to offer seamless SHARE integration Allows MDR users to pull automated updates

• IMI eTRIKS implementing also

• Aim to eliminate the need to manually load standards content into MDRs and other software

• Will require additions to the SHARE technical and support infrastructure

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© CDISC 2015

Keep up with eSHARE News• Periodically check the website

http://cdisc.org/cdisc-share

• CDISC Newsletter• Follow our Social Media:

Twitter: follow @CDISC, @cdiscSHARE, @swhume LinkedIn Group: CDISC CDISC Facebook Group

• SHARE space on the CDISC Wiki http://wiki.cdisc.org

• Sam’s blog on SHARE topics http://mungingmetadata.blogspot.com/

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© CDISC 2015

European Activity

• Modus operandi established between EMA and CDISC Leadership, monthly calls

• MOU with IMI – eTRIKS & Biovacsafe projects, EHR4CR• CTR in public review• Vaccines standard public review 2nd quarter 2016• Exploring fit of new EU CT Portal with CDISC standards• EMA rep on CFAST Scientific Advisory Committee• Staff hires – John Owen (Therapeutic Area Standards), Dorina

Bratfalean (Data Management expert), Paul Houston, Sue Smith - secretariat function.

• Relaunch of CDISC UK Network, Italian coming...• CDISC day Warsaw, 2016 Interchange Vienna

© CDISC 2015

Schema components

Based on CDISC ODM 1.3.2 Extended with the existing SDM-XML 1.0

(Study Design Model in XML) Especially for Trial Parameters (sdm:Parameter)

Additional elements for common CT.gov-EudraCT-WHO

content, not already covered by ODM

For very specific Eudra-CT content, incorporation of two Eudra-CT XML-Schemas

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© CDISC 2015

What can it be used for? Software vendors can develop software that provides a

“develop once, submit multiple” solution, i.e.

One software tool for generating CTR submissions to as well ClinicalTrials.gov as to Eudra-CT as to …

Starting from scratch or from an existing Study Design in ODM

Improve beginning to end integrity of data with extended protocol elements and SDM elements

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© CDISC 2015

PROTOCOL pieces and projects

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SDM

PRM

CPT CTR

RDF

TransCelerate

PhUSE

BRIDG

CDISC

© CDISC 2015 20

•Project ‘Optimus’ as a second stage of CDISC CTR will focus on defining fully structured protocol and results summary elements. The CTR2 standard will therefore utilize and necessitate the development of a new Protocol standard – PRIMe. The goal of the new standards being:

• driving further harmonisation of International Registry requirements between stakeholders

• to advance the beginning to end support of clinical trials

• Ensure that IDMP elements are mapped to CTR2 and PRIMe

CTR2

Protocol Representation Implementation Model - executable

Clinical Trial Registration & Results 2

PRIMe

Project Optimus - Project Goals

© CDISC 2015

PRIMe & CTR2 Combined drivers

• Achieve true beginning to end support of clinical trial elements• Create great efficiencies within development programs using

CDISC standards• Easier reuse of trial designs• Data quality gains through information management

improvements• Enabling re-use of content• IDMP(ISO Identification of Medicinal Products) inclusion to

increase the depth and quality of information relating to medicinal products , substances etc

• Support better Pharmacovigilance and research• Effective searching against clinical trial databases etc…

© CDISC 2015

Registration Now Open for the CDISC Day in Warsaw

Join us in Warsaw, Poland on 19 February 2016 to learn about CDISC. This one-day event will cover important CDISC topics such as: CDISC Standards and Implementation Experiences CDISC/CFAST Therapeutic Area Standards SHARE Metadata Repository CDISC Education and Collaborations in Europe, e.g. IMI and EMA 2016 CDISC Europe Interchange

View the preliminary agenda.

Seats are limited, register by 15 February!Click here to register and pay by credit card

Click here to register and pay by invoice

Interested in increasing the visibility of your company? Take advantage of CDISC sponsorship opportunities. Contact dharakeh@cdisc.org for more information.

© CDISC 2015

CDISC Interchange in 2016

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www.cdisc.org/Events

Abstracts:Call for abstracts is now open. Deadline: 4 January 2016Submit your abstract today!

© CDISC 2015

October 2016 – CDISC 2 day Workshop at EBI + SHARE/TA day

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• 2 day Clinical Research Advancements Workshop – 19th-20th • CDISC Day –Therapeutic Areas & SHARE - 21st October