F-CRIN, TOGETHER TO SUPPORT CLINICAL RESEARCH IN FRANCE

Transcription

1 F-CRIN, TOGETHER TO SUPPORT CLINICAL RESEARCH IN FRANCE 1

2 F-CRIN : HOW AND WHY? A national and European challenge to Strengthen the most promising of French Clinical Research to Europe A structure funded by the French government: Investissements d Avenir Call in millions for 8 years A common collaboration with all national partners of the academic clinical research: INSERM, CNCR (National Committee for Research Coordination), Hospitals, Universities A partnership with Healthcare Industries (ARIIS ) 2

3 F-CRIN = a Shared Project A Common Goal The hub for a national access to sponsors and investigators : 1. To support big multicenter academic clinical trials 2. To reinforce the participation and the coordination of European projects by French clinical teams 3. To foster industrial Proof- of-concept studies in innovative therapies Financial Resources 20M 3

4 ACTION PLAN : 5 ITEMS 1. Select platforms and investigational networks able to provide support to innovative projects in France and Europe 2. Propose shared clinical trials procedures to the different academic research partners 3. Help the set up and the management of complex European/international projects 4. Professionalize clinical research jobs through training 5. Be the French component of the ECRIN Network 4

5 1ST GOAL Select Platforms and Investigational Networks able to provide support to innovative projects in France and Europe. 2 Platforms EUCLID (Bordeaux) PARTNERS (Paris) 2 Crossectional facilities ORPHANDEV (rare diseases) TECH4HEALT H (medical devices) 8 INIs Investigators Network Initiative FACT (Cardiovascular) FORCE (Obesity) IMMIDIATE (Auto-immune and Autoinflammatory diseases) INI-CRCT (Cardiovascular and Renal) INNOVTE (Thrombosis) I-REIVAC (Vaccinology) NS-PARK (Parkinson s disease and Movement Disorders) TRIGGERSEP (Sepsis) 5

6 F-CRIN, operational structure providing services to investigators & sponsors to support clinical research projects 6

7 FINANCIAL CONDITIONS TO ACCESS THE SERVICES A same «Price list» for «Platforms/INIs» An access to excellence which has a price An expected return on investment for F-CRIN (in accordance with the of «Inv.d avenir») 7

8 2ND GOAL Propose shared clinical trials procedures to the different academic research partners 2 Workpackages involved : WP3: Coordination of services and portal access WP4: Tools and common procedures (Quality Assurance ; Management, PV ) 8

9 3RD GOAL Help the set up and the management of complex European/international projects Alchemist Sympath 9

10 ONGOING IND.PROJECTS IND. Project EN SponsorCOURS Funding Indication Role of FCRIN POC «BN IPSEN MSA-DOPS Pierre Fabre Innovation CHU Toulouse Pierre Fabre PF/ FCRIN Conception; Support IPSEN + FOX Dyskinésies chez le parkinsonien for management Supervision QA PHRC + Effets du L-ThreoDOPS sur l HO monitoring; Data Chelsea de l AMS management Récupération fonctionnelle. Etude imagerie et sujet sain AFFIRIS 009 AFFIRIS AG (Autriche) POC «NLX-112» Neurolixis FP7 AFFITOPE vaccines, in patient with (MSA) Neurolixis/FOXDyskinésie Parkinson Bumétamide Neurochlore Neurochlore Parkinson Vaccination zona chez les Vaccin Zona/VIH GSK GSK patients VIH SANOFI- Vaccin ClostridiumSanofi-PasteurPASTEUR COUPER Bayer Bayer Cohorte embolie pulmonaire 10 Monitoring, Training, Quality control Conception; support to carry out Conception; Support for management Support for management Support for management Conception; Support for management 10

11 SUPPORT TO EUROPEAN PROJECTS Project Thematic Indication Coordinator NS Park D Devos PHC 13 Mal Rares S de Kramer PHC 5 CRCT P Rossignol Retreat Frail PHC 17 INNOVTE / Symptoms D Parkinson ; chélation FE Protéomique fœtale et valve urétrales post HTA 3 âge institution CHU Lille Inserm Inserm Mottier PHC 13 AC et sujets âgés CHU Brest Chir bariatrique FORCE M Laville PHC 17 sujets âgés CRNH Lyon FACT G Steg PHC 13 IL2 et IdM Inserm INNOVTE / RECIDIVES G Meyer PHC 5 récidive VTE Inserm sepsis âgé en réa TRIGGER SEP PHC 17 Inserm PARTNERS/ K Chevreul mhealth prévention suicide en soins primaires 11

12 4TH GOAL Professionalize clinical research jobs through training F-CRIN initiative European and international projects set -up Train the trainer to clinical research for investigators F-CRIN partnership Methodology for Clinical research in movements disorders with Movement Disorders Society Méthodology For Clinical trials in Rare Diseases with OrphanDev Clinical research and Innovation in the hospital with EHESP 12

13 5TH GOAL As French component of access to the European level, the EuCo EuCo EuCo EuCo EuCo = European Correspondent 13

14 ECRIN-ERIC AND ITS PARTNERS ECRIN ERIC not-for-profit organisation MEMBER Scientific Partners (national networks & hubs) MEMBER EC OBSERVER framework contracts on provision and costs of services quality assurance MEMBER EC Core Team EC NON MEMBER single contract with sponsor third parties PIC AFFILIATE PARTNER AFFILIATE PARTNER Data centres NON MEMBER 14

15 LE PROGRAMME Comité Essais cliniques Europe France 15 15