EUROPA ~ WP4 Clinical research Executive

Organisation ( CREO)

Paris, September 2004

WP4 activities overview

Objectives - To establish a EuroPa clinical research and trial organisation for conducting industry-independent and industry-sponsored studies : Clinical Research Executive Organisation (CREO) - To select and design a first research project by the end of the funded period

Responsible partners: Toulouse, in collaboration with Lisbon, Marburg and all EuroPa partners

WP4 activities – Tasks to be accomplished

- Meeting with all partners and centres willing to participate in clinical studies;- Establishment of an executive committee;- Definition of procedures to decide which studies will be performed;- Definition of work flows for designing protocols and electronic case report forms;- Adaptation of the general EuroPa databank to the specific needs of a research clinical trial (RCT);- Definition of monitoring procedures and services needed;- Establishment of a strategy for web-based patients and study centre recruitment;- Initiation of and providing a co-operation with a biometrics department;- Planning an investigator initiated study as an example of a RCT;- Applying for funding of this RCT

WP4 deliverables

1st meeting of the RCT specialist group month 0

Organigram of the structure month 12

2 nd meeting of the RCT specialist group month 18

Manual describing procedures (C.Sampaio) month 24

Study protocol of the first RCT month 30

3 rd meeting of the RCT specialist group month 32

Electronic case report form for the first RCT month 36

Final report month 36

WP4 milestones

Identified RCT month 24Designed RCT month 30

Prepared application for external funding month 36

WP4 Accomplished deliverables (1)

1st meeting of the RCT specialist group month 0Frankfurt, January 31 2002 ~ start-up (plenary) meeting (contractorscouncil) including all project members, definition of objectives and offirst working procedures for WP4

Organigram of the structure month 12- Recruitment of WP4 manager (December 2002)-CREO constitution (Toulouse - May 31, 2002; Barcelona -July 12,2002; Lisbon - July 13-14, 2002; Frankfurt - July 25, 2002; Vienna –October 27, 2002; Miami - November 10, 2002; Frankfurt January 9,2003 )

2 nd meeting of the RCT specialist group month 18Barcelona – July 11, 2003

WP4 Accomplished deliverables (2)

Manual describing procedures month 24CREO procedures (Jan’04); SOPs ongoing (C. Sampaio)

Study protocol of the first RCT month 30Aug’03: Process for project call; Nov.’03 : Call for project;Dec’03 : Reception of 4 proposals; Jan’04 : CREO meeting in Toulousefor projects selection process; Feb’04 : Circulation of proposalsamong steering committee and conf calls ; Mar’04 : study selectionprocess (conf call + face/face meeting in Lisbon); July’04 final draft ofthe selected protocol and conf call

3 rd meeting of the RCT specialist group month 32May’04 : final selection by SC (conf call) ;

CREO objectives(1)

- To facilitate, conduct and manage clinical research project

1-Centres accreditation

2- Select project

3- protocol redaction

4- CRFs & others supports writing

5- Ethics & legal aspects

6- Budget plan & funding

7- implementation of the project

- To organise and manage CREO resources

- To guaranty transparent information and fair access to all EuroPa partners

8- data collection

9- monitoring

10- data entry

11- data management

12- data analysis

13- study report

14- publication

CREO Organisation

• Role and responsibilities

• 11 EuroPa partners

• Steering Committee

• Scientific advisory board

• Executive Board

• Executive team

• Study Steering Board

CENTRE ACCREDITATION

EuroPa STEERING COMMITTEE

SCIENTIFIC ADVISORY BOARD STUDY STEERING

BOARD

STUDY PREPARATION

QUALITY CONTROL

STUDY FOLLOW-UP

DATA MANAGEMENT

DATA ANALYSIS

STUDY REPORT

EXECUTIVE BOARD

EXECUTIVE TEAM

SU

BC

ON

TR

AC

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11 EuroPa PARTNERS

CREO Executive Board (1)

Members O. Rascol, C. Sampaio, W. Oertel up to the end of the EU;

Responsibilities • To give final approval on CREO activities • To supervise their implementation and progress. • To call for research projects & activities, • To assess the feasibility of scientific projects proposed by the scientific

advisory board, • To identify the needs of a project, • To set up the budget • To distribute the tasks for study conduction to internal facilities if available or

to external subcontractors (like CROs for example) according to availability and expenses.

• To participate in communication and fundraising activities.

CREO Executive Board (2)

Functioning

• Report to the steering committee

• Meeting on a monthly basis (telephone, face /face)• Chair : bi-annual rotation – (W.Oertel Jan-Jun’04; C.Sampaio Jun-Nov’04)

• Decision making process : by consensus (common agreement of the 3 CREO members). In the absence of consensus, the decision is submitted to the steering committee final decision.

• Supported by a CREO Executive Team

CREO Executive Team (1)

• Members: Managers designated by the Executive Board (at least one designated representative of

Toulouse, Lisbon and Marburg).

• Responsibilities To accredit centres based on accreditation policies (abandonned) To write EuroPa Standard Operation Procedures (SOP) for the 14 tasks (ongoing –

C.Sampaio) To track studies budget To co-ordinate Study Teams after the approval by the CREO Scientific Advisory Board To propose appropriated resources to ensure that project activities are performed in line

with prevision regarding timing and budget To co-ordinate overall research activities from protocol initial phases until publications,

i.e. data management plan & organisation, data analysis plan & organisation, study report, compliance to publication policies

CREO Executive Team (2)

Functioning

• Report to the CREO Executive Board at least once a month.

• Meeting on a weekly basis (face to face or via teleconferences)

• Communication : Day by day work will take place via E-mail or telephone at the individual location.

CREO Scientific Advisory Board (1)

• Members: 1 representative designated by each of the 11 EuroPa clinical partners (Austria: W. Poewe, Czech Republic: E Ruzika, France: O. Rascol, Germany: W. Oertel, Israel: R. Djaldetti, Italy: P. Barone, The Netherlands: N. Leenders, Portugal: C. Sampaio, Spain: E. Tolosa, Sweden: H. Widner, UK: A Lees)

• Responsibilities To select projects proposed by EuroPa members To submit selected projects to the Executive board for feasibility assessment

according to EuroPa SOPs To define priorities among selected projects To ensure that all members will have a fair opportunity to propose and to

participate into research projects. To designate a Principal Investigator (PI) for each project To regularly update CREO activities to all partners

CREO Scientific Advisory Board (2)

Functioning

• Reporting : steering committee • Chair : rotating on annual basis – 2004: C. Sampaio• Decision making process : voting system (each

representative will have 1 vote)• Meeting on a 6-month basis in association with another

meeting to save resources.

CREO Study Steering Board (1) Members

Investigators, study staff (ie statistician, monitors,...) and will beSpecifically appointed for each project

Responsibilities• To design and to write the protocol• To design and to write appropriate study guidelines before anything is starting• To select participating centres and to set up a study scientific committee• To define centre commitments • To track study budget • To co-ordinate various scientific and logistic aspects (printing, sending, meetings,…) within the agreed

budget together with the CREO Executive Team. • To track patients recruitment. • To ensure that all different CREO teams and boards are kept informed of any factors which might impact

the project and the budget • To propose a publication plan in relation with the project • To write at least 1 study publication • To update CREO Executive Team every month on project advancement status to all partners

CREO Study Steering Board (2)

Functioning

• Reporting : executive board/ executive team/ study scientific committee

• Chair : principal investigator • Decision making process : Principal investigator with the

approval of the executive board/executive team/ study scientific committee

• Meeting on a weekly basis

First EuroPa project

CROSS SECTIONNAL STUDY OF CHRONIC PAIN AMONG

AMBULATORY PARKINSONIAN PATIENTS LIVING IN 11

EUROPEAN COUNTRIES

Cross-sectional epidemiological type with full service-“light” logistic- “low” costs- “rapid” results

Hypothesis

- The prevalence of chronic pain in PD is high, up to 50%, according to the last published survey in 1986 ;

- Chronic pain could be associated with some markers of PD (severity, Dopa responsive or Dopa resistant symptoms, anxiety, depression, insomnia);

- Chronic pain in PD has a significant impact on quality of life;

Objectives

• To evaluate the prevalence of chronic pain among ambulatory Parkinsonian patients living in various countries of Europe;

• To describe and compare the profile of Parkinsonian patients whether they feel pain or not;

• To evaluate the repercussion of chronic pain on the quality of life of the Parkinsonian patients.

Patients

• 600 ambulatory PD patients to be included

• ~ 50 first patients seen at each centre

OUTCOME CRITERIAS

• Principal outcome - Specific questionnaires about chronic pain in

Parkinson’s disease (in preparation – To be discussed)

• Secondary outcomes- To assess PD severity (Hoehn and Yahr, UPDRS,

Schwab and England)- To assess chronic pain [visual analogic scale, short

version of the Mc Gill pain questionnaire (if validated translation are avalaible)]

- To assess quality of life (PDQ39, SF36)

ESTIMATED BUDGET

• Investigators/ centres (1 day doctor/centre/week) : 50 000 €• Material (CRFs, etc...) 15 000 €• Translation costs 20 000 €• Study implementation (meetings) 25 000 €• Monitoring 60 000 €• Project coordination 25 000 €• Data management & analysis 50 000€• Publication & Communication 5 000€

• TOTAL 250 000 €

TIME TABLE

• Project inception and preparation 9 months• Project implementation and data collection 9

months• Data analysis and publication 6 months