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EuroPa Clinical Research Organization: Objectives and Accomplishments

Learn about the establishment of the Clinical Research Executive Organization (CREO) for conducting clinical studies, objectives, key tasks, deliverables, milestones, and the functioning of the Executive Board.

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EuroPa Clinical Research Organization: Objectives and Accomplishments

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  1. EUROPA ~ WP4 Clinical research Executive Organisation ( CREO) Paris, September 2004

  2. 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

  3. 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

  4. 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

  5. WP4 milestones Identified RCT month 24 Designed RCT month 30 Prepared application for external funding month 36

  6. WP4 Accomplished deliverables (1) 1st meeting of the RCT specialist group month 0 Frankfurt, January 31 2002 ~ start-up (plenary) meeting (contractors council) including all project members, definition of objectives and of first 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 18 Barcelona – July 11, 2003

  7. WP4 Accomplished deliverables (2) Manual describing procedures month 24 CREO procedures (Jan’04); SOPs ongoing (C. Sampaio) Study protocol of the first RCT month 30 Aug’03: Process for project call; Nov.’03 : Call for project; Dec’03 : Reception of 4 proposals; Jan’04 : CREO meeting in Toulouse for projects selection process; Feb’04 : Circulation of proposals among steering committee and conf calls ; Mar’04 : study selection process (conf call + face/face meeting in Lisbon); July’04 final draft of the selected protocol and conf call 3 rd meeting of the RCT specialist group month 32 May’04 : final selection by SC (conf call) ;

  8. 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

  9. CREO Organisation • Role and responsibilities • 11 EuroPa partners • Steering Committee • Scientific advisory board • Executive Board • Executive team • Study Steering Board

  10. 11 EuroPa PARTNERS EuroPa STEERING COMMITTEE EXECUTIVE BOARD SCIENTIFIC ADVISORY BOARD STUDY STEERING BOARD EXECUTIVE TEAM CENTRE ACCREDITATION STUDY PREPARATION QUALITY CONTROL STUDY FOLLOW-UP SUBCONTRACTORS DATA MANAGEMENT DATA ANALYSIS STUDY REPORT

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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.

  17. CREO Study Steering Board (1) Members Investigators, study staff (ie statistician, monitors,...) and will be Specifically 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

  18. 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

  19. First EuroPa project CROSS SECTIONNALSTUDY 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

  20. 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;

  21. 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.

  22. Patients • 600 ambulatory PD patients to be included • ~ 50 first patients seen at each centre

  23. 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)

  24. 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 €

  25. TIME TABLE • Project inception and preparation 9 months • Project implementation and data collection 9 months • Data analysis and publication 6 months

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