Adding randomisation capabilities to MACRO Emile van der Donk Nederlands Kanker Instituut e'vd'donkn

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Adding randomisation capabilities to MACRO
Emile van der DonkNederlands Kanker
Instituute.vd.donk_at_nki.nlMacro User Meeting

• 1/2 June 2005
• Liverpool( )

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Presentation outline

• The TENALEA project
• ALEA Randomisation software
• How ALEA integrates with MACRO
• Demo
• Service availability

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Project Introduction

• The main objective of TENALEA is
• to reduce the administrative overhead in clinical
  trials data management for the participating
  clinician, the study site and coordinating data
  centre. In order to reach this objective,
• the primary goals of TENALEA are
• to harmonise at a European level clinical trials
  data management procedures and in particular
  randomisation procedures, and to make available
  online clinical trials data management tools
  which follow these harmonised procedures.
• 18 months June 2004 to November 2005
• 5 Academics, 1 Pharma, 1 Software company
• MARKET VALIDATION, NOT RD!

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Phases, milestones and participation
1996 2004 2005
2009
Research Development
Market Validation
Initial Deployment
Full Deployment
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Tool to validate ALEA

• ALEA is software for patient randomisation in
  clinical trials through web or IVRS
• Supports all accepted randomisation methods and
  study designs
• Has comprehensive notifications system
• Has been in use for over 10 years
• Is offered as a shared service

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Problems for investigator

• 100 clinical trials, 30 different procedures for
  randomisation
• Multiplicity of different systems due to
• Shift from paper based randomisation to online
  randomisation
• Shift from paper based CRF to eCRF

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For the data centre

• Maintaining custom randomisation software
• Per study programming
• QA Requirements
• EU directive
• FDA
• Randomisation methods are evolving

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ALEA Supports randomisation with
IVR
PDA / SmartPhone
FAX
WEB
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Trans European Randomisation Service
Coordinating data center
Investigator
Point of randomisation
FAX
Coordinating data center
Investigator
Coordinating data center
Investigator
Coordinating data center
WEB
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Validation steps

• Verify requirements with Academic consortium
  members
• Operate TENALEA for Academic partners
• Verify Requirements with Pharma
• Verify service with interested groups outside the
  consortium

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WP6 MACRO ? ALEA

• What works
• Randomisation Form completed in MACRO ends up in
  ALEA
• Randomisation Form completed in ALEA ends up in
  MACRO
• Whitelist synchronisation
• Sites synchronisation
• What does not work (yet?)
• Exchange of form definitions

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SCENARIO 1 MACRO form forwarded to ALEA
4. ALEA-MACRO proxy converts plaintext MACRO data
to ODM call
5. ALEA ODMProcessor performs randomisation and
returns treatment allocation to MACRO
6. ALEA Database includes new subject
3. MACRO server sends registration request to
MACRO-ALEA proxy
2. MACRO stores formdata in MACRO database

• Form is completed in MACRO Data Entry and
  submitted to MACRO server

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SCENARIO 2 ALEA form forwarded to MACRO
5. MACROAPI inserts the new subject into the
MACRO database
4. ALEA-MACRO proxy converts ODM to MACROAPI calls
6. MACRO RDE includes the new subject
3. ALEA server sends form in ODM format to
MACRO-ALEA proxy
2. ALEA server performs randomisation
1. Form is completed in ALEA and submitted to
randomisation server
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DEMO- Randomisation definitionOnline
randomisationNotificationsInteractive Voice
Response
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Service availability

• 2005 through NKIAVL Amsterdam
• Validate TENALEA service
• Send us a randomisation forminvestigators list
• We make a site and put your randomisation there
• You test, and see whether you like it
• If you like it, you may put studies in yourself
• Initial Deployment project submitted May 2005
• tenalea_at_nki.nl or e.vd.donk_at_nki.nl