29/08/2003

Midterm Review MeetingHelsinki

29.08.2003 Midterm Review Meeting, Helsinki 2

Overall Objective

Research Infrastructure

The establishment of a synergistic European network

that bundles and coordinates existing competence in

clinically oriented research on Parkinson’s disease.

Network management (WP 1) – committees

voting rulespublication policy

29.08.2003 Midterm Review Meeting, Helsinki 3

Who are we?

Neurologists with long-term

experience and expertise in

movement disorders and

clinical research from 11

European countries and

an IT- partner

29.08.2003 Midterm Review Meeting, Helsinki 4

EuroPa: Work Packages Overviewproject

managementdata

managementregistry clinical

research + trial organisation

economics fundraising

WP 1 WP 2 WP 3 WP 4 WP 5 WP 6

Marburg 1 XX X X (XX) X X

London 2 X X X X X

Toulouse 3 X X X XX X X

Groningen 4 X X X X X

iAS 5 X XX (XX) X

Bonn 6 X XX

Jerusalem 7 X X

Lisboa 8 X (XX) X

Lund 9 X X

Barcelona 10 X X XX

Naples 11 X X

Prag 12 X X

Innsbruck 13 X XX X X

x – involved partner, xx – responsible partner, (xx) – in collaboration responsible

29.08.2003 Midterm Review Meeting, Helsinki 5

What are we aiming for?

Recruitment of clinically well described patients

- unified clinical documentation

- minimal data set (WP 3) - registry

Web-data entry system (WP 2)

- including data management

Main achievement will be a central patient registry

Advantage for EuroPa in planning and conducting

multinational, multicentre clinical trials (WP 4)

29.08.2003 Midterm Review Meeting, Helsinki 6

What are we aiming for?

Spread of Good Clinical Practice (WP 4) Accelerate the standardization of diagnostic and therapeutic strategies

EuroPa is qualified to conduct - epidemiological studies (WP 4) - socio-economical studies (WP 5)

with impact on patients, the health care system and the society

To raise funds for sustainability (WP 6)

Long term goal: clinical research organisation for European multicentre clinical trials

29.08.2003 Midterm Review Meeting, Helsinki 7

EuroPa: Timetable

partners

months 6 12 18 24 30 36

WP1 #1-5,13

Definition of quality standards Establishment of EuroPa as independent organization

WP2 #1-5

Working version of the web site

Functioning web-based data entry system

WP3 #1-5,7-13

Start of data entry Inclusion of 1000 patients 4000 patients

WP4 #1-13

Identified a RCT Designed RCT

Application for external funding

WP5 #3,6,8

Statement 1 Analytic model

WP6 1-4,10,13

Completion of the funding survey

Implementation of a business plan

meetings

CC

SG

First Year Second Year Third Year Reference:

„EuroPa“ - Technical AnnexPages:13-14

„EuroPa“ - Proposal Part BPages: 18-20

29.08.2003 Midterm Review Meeting, Helsinki 8

Where are we now?

• More than half of the project funding period is over

• We have proceeded within schedule

• Important milestones have been reached in time

• Participants increasingly identify themselves with EuroPa

Details of project progress will be presented by the work

package leaders

29.08.2003 Midterm Review Meeting, Helsinki 9

Summary

Main project achievements so far:Establishment of a functioning management structureData protection and ethical approvals in most centresPatient registry with web-based data capture is working – on-lineAbout 350 patients have been entered Concept of EuroPa clinical trial and research organisation (CREO) is finalizedA call for proposals for the first EuroPa study has just been sent out to all participantsPossible organisational forms for EuroPa are under evaluation in order to ensure our sustainability