MACRO in the academic user community

1
MACRO in the academic user community

• MACRO User Group Meeting
• 1.-2. June 2005, Liverpool
• Thomas Bratke, Michael Wittenberg, Muriel
  Wartelle, Asaf Niaz
• Coordination Centre for Clinical Trials Cologne
  / Marburg, Institut Gustave-Roussy, Roy Castle
  Lung Cancer Foundation

2
List of Abbreviations

• ARFG Academic Research Focus Group
• EDC Electronic Data Capture
• IGR Institut Gustave-Roussy
• KKS Coordination Centre for Clinical Trials
• BMBF German Ministry for Education and Research
• TMFe.V. Telematics Platform for German
  Medical Research Networks

3
Content

• Overview ARFG
• ARFG highlights
• Institut Gustave-Roussy in the ARFG
• KKS Germany in the ARFG
• MACRO projects funded by the German Telematics
  Platform (TMF e.V.)

4
Overview ARFG

• UK
• Cancer Research
• Medical Research Council Clinical Trials Unit
• Institute of Cancer Research
• Roy Castle Lung Cancer Foundation
• European Fungal Infection Study Group
• Diabetes Trial Unit, Oxford
• Clinical Trials Research Unit (North Yorkshire)
• Scottish Cancer Therapy Network
• Wales Cancer Trials Network
• Netherlands
• Netherlands Cancer Institute
• Italy
• National Cancer Institute, Naples

• Germany
• Institute of Medical Informatics Biometrics
  Dresden
• KKS Marburg
• KKS Cologne
• KKS Freiburg
• KKS Dresden
• KKS Mainz
• KKS Heidelberg
• KKS Muenster
• France
• Institut Gustave-Roussy (IGR)
• Institut Curie
• Institut Bergonié
• Centre Alexis Vautrin
• INSERM Unit 605

• 24 Academic MACRO users are meeting in the ARFG
  twice yearly

5
Overview ARFG

• Meetings 2004
• 2nd March 2004, Cancer Research UK, Cambridge
  Terrace, London
• 13 groups joined the meeting
• 10th September, Institut Curie, 26 rue dUlm,
  Paris
• 17 groups joined the meeting
• Meetings 2005
• 18th March 2005, DOMFORUM, Domkloster 3, 50667
  Cologne
• 17 joined the meeting
• 2nd September 2005, exact venue to be announced,
  Bordeaux

• Active, lively and vibrant MACRO user (sub) group

6
Content

• Overview ARFG
• ARFG highlights
• Institut Gustave-Roussy in the ARFG
• KKS Germany in the ARFG
• MACRO projects funded by the German Telematics
  Platform (TMF e.V.)

7
ARFG highlights

• Regular tasks
• User experience reports
• General MACRO usage
• Technical issues
• Data management issues
• Communication and information exchange with other
  academic users and InferMed
• Presentations and priorities discussion on/about
  further MACRO developments

8
ARFG highlights

• MACRO usage example
• MACRO biometric identification
• European Early Lung Cancer Detection Trial, Roy
  Castle Lung Cancer Foundation
• MACRO online EDC trial, 15 sites, 45 users, 800
  patients
• ISLs biometric API

9
ARFG highlights

• MACRO usage example
• German National HIV registry study
• 10.000 HIV patients in Germany
• High data security requirements
• 50 German participating sites
• 6.000 recruited and documented patients since
  08/2004
• Training / Laptop validation / Help Desk
• Online EDC reports for participating sites and
  patients
• MACRO offline EDC trial (academic)

10
ARFG highlights

• MACRO usage example
• TENALEA project
• main objective reduce the administrative
  overhead in clinical trials data management for
  the participating clinician, the study site and
  coordinating data centre
• primary goals harmonise at a European level
  clinical trials data management procedures and in
  particular randomisation procedures
• MACRO online randomisation

11
Content

• Overview ARFG
• ARFG highlights
• Institut Gustave-Roussy in the ARFG
• KKS Germany in the ARFG
• MACRO projects funded by the German Telematics
  Platform (TMF e.V.)

12
Institut Gustave-Roussy (IGR) in the ARFG

• French cancer treatment centre with
• Treatment
• Education
• Research (11 units)
• 9 CNRS or INSERM Laboratories
• 2 University laboratories
• 400 beds / 2.350 staff
• 11.000 new patients / 150.000 patients visit per
  year
• 177 ongoing trials in 2004

13
IGR in the ARFG
14
IGR in the ARFG

• MACRO, in use in the Biostatistics and
  Epidemiology unit since 2003
• 30 users,
• No remote data entry
• 18 studies opened for inclusion
• 6 studies closed for inclusion
• 14 studies in preparation
• TenAlea Project partner
• French market validation
• 20 French cancer centres
• 11 Public Clinical Research Unit
• 6 studies opened for inclusion
• 4 studies in preparation

15
Content

• Overview ARFG
• ARFG highlights
• Institut Gustave-Roussy in the ARFG
• KKS Germany in the ARFG
• MACRO projects funded by the German Telematics
  Platform (TMF e.V.)

16
KKS Germany in the ARFG locations
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KKS Germany in the ARFG scope

• supporting scientifically-driven ("investigator
  sponsored") non-profit clinical trials
• initiating, planning and performing innovative
  and competitive national and international
  clinical trials
• implementation of harmonized quality management
• training related to scientific and organizational
  aspects of trials (e.g. study nurse courses,
  investigator courses)
• long-term establishment of the coordination
  centres with university support and
  pharmaceutical industry cooperation
• supporting EDC and Mobile Computing for clinical
  studies

18
KKS Germany in the ARFG finance

• initiated and sponsored by the BMBF ?
  (decreasing over 6 years)
• individually supported by the medical faculty of
  the university ? (permanent)
• pharmaceutical industry and public research
  funded trials ? (increasing)

19
KKS Cologne clinical trials overview
20
Content

• Overview ARFG
• ARFG highlights
• Institut Gustave-Roussy in the ARFG
• KKS Germany in the ARFG
• MACRO projects funded by the German Telematics
  Platform (TMF e.V.)

21
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• TMFe.V.
• ...In order to identify and resolve the common
  problems of working as an
• integrated network, some of the leading medical
  research groups in
• Germany have joined together to form the
  Telematics Platform for
• Medical Research Networks (TMFe.V.)...
• ...Membership of TMF includes all the Medical
  Speciality Research
• Networks (Competence Network), the twelve
  Clinical Study Coordination
• Centres (KKS), the National Genome Research
  Network, various
• networks for rare diseases and some additional
  medical research
• groups...
• ...Under the TMFe.V. umbrella they develop
  telematics and
• organisational solutions that take the needs of
  such networks into
• account...

22
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 1 IT system validation in the academic
  environment
• Project 2 CDISC data exchange as a standard for
  data management
• Project 3 Mobile Computing evaluation in the
  academic environment

23
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 1 IT system validation in the academic
  environment
• Aim
• Data management quality assurance in scientific
  networks according to imposed national and
  international regulations (FDA, EU Directive,
  GCP) with special regards to limited academic
  resources
• Availability of generic and specific documents
  (SOPs, Templates, Check lists)
• Standard system validation establishment
• Practical local system validation support
• System validation knowledge transfer ? standard
  validation training concept

24
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 1 IT system validation in the academic
  environment
• Results
• Validation documents consolidation - completed
• System Validation Master Plan (SVMP) -
  content to be finalised
• External vendor audit - in development
• TMF e.V. internal system - in developmentvalidat
  ion audit concept
• Internal training procedures - in development
• Final report - outstanding

25
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 1 IT system validation in the academic
  environment
• Funding
• 114.000 EUR
• Timeline
• Start January 2005
• End October 2005
• Contact persons
• michael.wittenberg_at_med.uni-marburg.de
• ronald.speer_at_kksl.uni-leipzig.de

26
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 2 CDISC data exchange as a standard for
  data management
• Aim
• Public evaluation report of CDISC need,
  deployment, usage and implementation state within
  the TMF e.V. scientific networks

27
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 2 CDISC data exchange as a standard for
  data management
• Results CDISC implementation analysis

• Software providers are conservative to implement
  CDISC because of uncertainty of CDISC role in HL7
  and uncertainty of costumer request

28
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 2 CDISC data exchange as a standard for
  data management
• Funding
• 15.000 EUR
• Timeline
• Start September 2004
• End April 2005
• Contact persons
• kuchinkw_at_uni-duesseldorf.de
• swen.wiegelmann_at_kksk.de
• thomas.bratke_at_kksk.de

29
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 3 Mobile Computing evaluation in the
  academic environment
• Aim
• Public analysis and evaluation report of Mobile
  Computing needs, usage and implementation state
  within the TMF e.V. scientific networks

30
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 3 Mobile Computing evaluation in the
  academic environment preliminary results

• Mobile Computing has a high importance in many
  scientific networks

31
MACRO projects funded by the German Telematics
Platform (TMF e.V.)

• Project 3 Mobile Computing evaluation in the
  academic environment
• Funding
• 15.000 EUR
• Timeline
• Start January 2005
• End June 2005
• Contact persons
• thomas.bratke_at_kksk.de
• kuchinkw_at_uni-duesseldorf.de