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© 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
5
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
6
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
12
© 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."
13
© 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
14
© 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
17
© 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
18
© 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 [email protected] 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