Conservative Iron chelation as a disease modifying strategy · Lille Toulouse Strasbourg Marseille...
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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 633190 Retour d’expérience: Mise en place du projet FAIR PARKII Coordonnator: Pr David DEVOS Sponsor: CHRU de Lille Date: 29/05/2017 Conservative Iron chelation as a disease modifying strategy in Parkinson’s Disease
Transcript of Conservative Iron chelation as a disease modifying strategy · Lille Toulouse Strasbourg Marseille...
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 633190
Retour d’expérience: Mise en place du projet
FAIR PARKII
Coordonnator: Pr David DEVOS Sponsor: CHRU de Lille Date: 29/05/2017
Conservative Iron chelation as a disease modifying strategy
in Parkinson’s Disease
Accompagnement au montage
de projet
• Cellule montage de projet du DRS du CHRU-Lille,
• Le Réseau NS PARK (labellisé F-Crin) a financé un accompagnement au montage (Inserm Transfert),
• 2 jours de relecture par le cabinet efficient dans le cadre du dispositif FRAPPE (dispositif mis en place par le Conseil Régional)
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Information about the call
• Two stage call: New therapies for chronic non-communicable diseases PHC-13-2014
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2013/12/11
• Publication date; EC contribution per project : 4-6 M€
• (60 M€ total budget for PHC 13 – 2014 i.e. 10-15 projects likely to be funded)
2014/03/11
• Deadline 1st stage
2014/05/15
• Information on the outcome of 1st stage evaluation
2014/08/19
• Deadline 2nd stage
2015/01/02
• Information on the outcome of 2nd stage evaluation
2015/01/21
• Negotiation meeting, Brussels
Résultats
Rédaction: Etape 1 -> Etape 2 Ligne PHC13: 296 propositions éligibles au stage 1 128 projets (43%) invités pour le stage 2 40 projets ont dépassé le seuil (12/15) après évaluation de la proposition complète (31%) 10 projets sur la short-list (7,8%) 5 projets sur la liste de réserve Overall success rate: 3,4% ESR de FAIR PARKII Score 14,5/15 Excellence: 5/5 Impact: 5/5 Quality and efficiency of the implementation: 4,5/5
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Meetings
• Negociation meeting: 21 January 2015
Withdrawal of a partner
Deliverables modification
Justification of subcontracting
Ethics requirements
• Signature of grant agreement March 2015
• Start date: 1 May 2015
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Meetings
• Kick-off meeting : 4-5 May 2015
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Presentation
• 16 partenaires, • Budget: 8,5 millions Euros, • Grant: 6 millions Euros • Duration: 5 years (60 months)
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Participant N° Participant organisation Short name Country
1 (coordinator) CHRUL France
2 INSERM France
3 ECRIN France
4 IT France
5 APOPHARMA Canada
6 IMM Portugal 7 FCRB Spain 8 UNEW UK
9 EKUT Germany 10 MUI Austria
11 CUP Czech Republic
12 RUNMC The Netherlands
13 EPDA UK
14 PUM Germany
15 UPMC France
16 UULM Germany
Presentation
• Multicentre, parallel-group, placebo-controlled, randomized clinical trial
• 24 centers in Europe ( 8 French centers and 16 European centers)
• 338 patients with de novo PD (169 patients per arm)
• 14 Patients/center (Inclusion period = 2 years)
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La mise en œuvre:
les conventions
• Task delegation Agreement:
ECRIN-ERIC & CHRUL
Identification of CTU (1 per country except France)
• National coordinator : selection of clinical centres – third parties
– Identified (or not) in DOA
• Feasibility ancillary studies
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La mise en œuvre:
Approvals (1/2)
• Competent Authorities:
Volontary Harmonisation procedure: Day of submission 17/08/2015
phase I: VHP request 5 days 24/08/2015
Phase II: CTA Assessment 60 days (median max 75 days)23/10/2015
phase III: National competent Autorithy 10 days 6/11/2015
Initial protocol approval date
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France Spain Austria Czech Republic
UK Portugal Germany Nether-lands
2016/01/26 2016/03/21 2016/01/18 2016/03/18 2016/02/24 2016/02/10
2016/02/04 NA
INFARMED
La mise en œuvre:
Approvals (2/2)
• Ethics Committee:
Initial protocol approval date
• Amendment approval Date
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France Spain Austria Czech Republic
UK Portugal Germany Nether-lands
2015/11/19 2016/03/10 2016/04/16 Submitted 2016/04/29
NA NA
NA NA
France Spain Austria Czech Republic
UK Portugal Germany Nether-lands
Competent Authority 2016/06/27
2016/07/07 In progress 2016/06/13 2016/08/22 2016/06/16 2016/06/10 2016/05/49
Ethical Comittee 2016/06/21
In progress 2016/07/22 In progress 2016/07/19 2016/04/18
NA 2016/08/09
Study initiation visits
• France
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Investigator/Site Name
Lille Toulouse Strasbourg Marseille Lyon APHP (Paris)
Clermont-Ferrand
Bordeaux
Study
Initiation
Visit
1-Feb-16 15-Mar-16 31-Mar-16 19-Apr-16 25-Apr-16 17-Mar-16 10-Mar-16 9-May-16
Expected
FPFV Date
20-Jan-16 18-May-16 NA
Actual
FPFV Date 9-Feb-16 10-Jun-16 1-Jun-16 17-June-16 23-Jun-16 18-May-16 27-July-16 21-Jul-16
Study initiation visits
• Spain
• Portugal
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Investigator/ Site Name
Hospital Clinic in Barcelona
Germans trials Hospital
Hospital Sant Pau
Study Initiation Visit 30-Aug-16 26/04/2017 15-Mar-17
Expected FPFV Date 10/11/2016
Actual FPFV Date 09/11/2016
Investigator/ Site Name
Centro Hospitalar do Alto Ave
Centro Hospitalare Universitario de Coimbra
Centro Hospitalar Lisboa Norte
Study Initiation
Visit 3-Apr-17 11/05/2017 Not planned yet
Actual FPFV Date 05/04/2017
Study initiation visits
• UK
• Germany
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Investigator/ Site Name
Cambridge Glasgow Newcastle
Study Initiation
Visit 11-May-2017
Do not participate
anymore 16-Aug-16
Expected FPFV
Date not planned yet
Investigator/ Site Name
Kiel Homburg Rostock
Study Initiation
Visit 9 Nov 2016 27 oct 2016 19 oct 2016
Expected FPFV
Date 14-Dec-16 not planned yet 21-Dec-16
Actual FPFV Date 14-Dec-16 21-Dec-16
Study initiation visits
• Austria Czech Republic
• The Netherlands
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Investigator/ Site Name
Medizinische Universitat Innsbruck
Study Initiation
Visit 17 oct 2016
Actual FPFV
Date 9 March 2017
Investigator/Site Name Radboudumc Academic Central Center
Study Initiation Visit 31-Aug-16 12-Jan-17
Expected FPFV Date 10-Nov-16 18-Apr-17
Actual FPFV Date 10-Nov-16 18-Apr-17
Investigator/ Site Name
Univerzita Karlova V Praze
Study Initiation
Visit 6 sep 2016
Expected FPFV
Date 7 Nov 2016
Inclusion and follow up
• F
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FAIRPARK II Contact
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NAME ROLE OFFICE
PHONE EMAIL
Pr Devos David Coordonnator +3 33 20 44 41 45 [email protected]
Mrs Pauline Guyon Project Manager +33 3 20 44 57 09 [email protected]
Dr Thavarak Ouk Pharmacovogilance +3 33 20 44 41 45 [email protected]
Mrs Lucile Marguet
CRA +3 33 20 44 41 45 [email protected]
Mrs Lydia Pop-Ilieva
ApoPharma Clinical Operations
Consultant (416) 401-7927 [email protected]
THANK YOU FOR YOUR
ATTENTION
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