23/01/2015. Les nouvelles structures (IHU et autres) Les petites dernières : les CRC. STRUCTURES de RECHERCHE CLINIQUE RECONNUES

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1 Les nouvelles structures (IHU et autres) 6 IHU sont labellisés en 2011 Personnes morales de droit privé, constituées en FCS (CHU). créés dans le cadre des structures labellisées à la suite des appels à projets financés par l ANR au titre du programme «INVESTISSEMENTS d AVENIR» financé par le «GRAND EMPRUNT NATIONAL» Structures pouvant comporter un partenariat hospitalier les LABEX (laboratoires d excellence), les EQUIPEX (équipements d excellence), Les IDEX (Initiatives d Excellence), Les IRT (Institut de Recherche Technologique), Les SATT (Société d Accélération de Transfert de Technologie) Brest Lille Amiens Caen Rouen Reims Nancy Rennes Angers Tours Nantes Dijon Besançon Poitiers Lyon Limoges Clermont Ferrand Saint Etienne Grenoble Bordeaux Nîmes Toulouse Montpellier Marseille Strasbourg Nice R.Poincaré HEGP Necker Bichat Cochin St Louis Robert Debré CNO 15/20 Pitié-Salpêtrière St Antoine IGR & Curie STRUCTURES de RECHERCHE CLINIQUE RECONNUES 27 CIC-P 9 CIC-EC 10 CIC-BT 8 CIC-IT 9 C/RTRS 6 IHU Albert Chenevier Henri Mondor Fort de France Pointe à Pitre GH Sud Réunion Les petites dernières : les CRC 28 Centres de Recherche Clinique (CRC) en 2012 ont été labellisés dans le cadre du 1 er appel à projets CRC lancé par la circulaire n DGOS/PF4/2011/329 du 29 juillet 2011 relative à l organisation de la recherche clinique et de l innovation et au renforcement des structures. Les CRC sont des plateformes d aide à l investigation, d aide à l inclusion et à l acquisition de données, d interface avec les patients et les volontaires sains pour les essais cliniques institutionnels et industriels (±CIC-P) pour les établissements de santé qui ne sont pas dotés de CIC (quelques CHU, les et certains CH). ne sont pas labellisés par l Inserm. D autres sont apparus depuis

2 Brest Lille Amiens Caen Rouen Reims Nancy Le Mans Rennes Angers Tours Nantes Dijon Besançon Poitiers Lyon La Roche-sur-Yon Annecy Limoges Clermont Ferrand Saint Etienne Grenoble Bordeaux Nîmes Toulouse Montpellier Marseille Strasbourg Metz Nice R.Poincaré HEGP Necker Bichat Cochin Robert Debré St Louis CNO 15/20 Pitié-Salpêtrière St Antoine IGR & Curie STRUCTURES de RECHERCHE CLINIQUE RECONNUES 27 CIC-P 9 CIC-EC 10 CIC-BT 8 CIC-IT 9 C/RTRS 6 IHU 28 CRC Albert Chenevier Henri Mondor Fort de France Pointe à Pitre GH Sud Réunion Un exemple l AP-HP 4 ème Institution Mondiale en Santé Evolution National Insitutes of Health United States 46,819 Partners HealthCare System 38,096 Veterans Affairs Medical Centers 36,902 AP-HP 36,013 Mayo Health System 23,743 INSERM 22,679 Duke Medicine 15,832 University of Texas M.D Anderson Cancer Center 13,800 Centers for disease Control and Prevention Estados Unidos 13,098 Cleveland Clinics 12,895 = N/A Score Scimago En nombre de places 2. Entrée dans le classement Source: Classement officiel Scimago 2011 Local & Regional Clinical Research Network in Paris Area ( Region) Local clinical research network of the University- Hospital (AP-HP) in Paris Area. Regional clinical research network (GIRCI) of the University- & non-university-hospitals in Paris Area ( Region) 6 2

3 AP-HP : the largest European University-Hospital - a network of 37 hospitals organized in 12 groups (GH) - 7 AP-HP : Facts and Figures > 3,000 clinical research projects in progress in projects with AP-HP sponsorship ( patients) 1,452 projects with industrial sponsorship 452 projects with academic sponsorship. 68 European projects. 918 professionals dedicated to research management 940 registered biological samples collection 487 portfolios of active patents filed 9,300 publications in 2013 MERRI 742,5 M related to academic activities (26% national grants) 8 Clinical Research & Development Department Strategy and expertise Development of research at AP-HP Implementation of all sponsorship regulations Funding, implementation, supervision and quality control of clinical research sponsored by AP-HP Management of clinical research activities Management of calls for projects Clinical trial pharmaceutical management Development of partnerships and transfer of technologies Learning courses Support of the design/management of European projects Budget : 56,2 M 9 3

4 Local Clinical Research Network inside the University Hospital (AP-HP) Due to a large number of research protocols 12 clinical research units were created in each GH devoted to the decentralized management of logistic assistance for research projects implementation organization of multicenter clinical trials in France, Europe clinical trial monitoring, quality control and data management stimulation of hospital clinical research activities Specialized units were also created, devoted to health economy, medical device evaluation, Cochrane center 17 CIC - 12 biological resources centers 10 Local Clinical Research Network of the University Hospital (AP-HP) Clinical Res. Units Clinical Res. & Development Department 11 Regional Clinical Research Organization in France - Seven Clinical Research & Innovation Networks : GIRCI

5 Public & Private Hospitals in Paris Area - Region - 13 Six Clinical Research & Innovation Offices are included into the GIRCI GIRCI Advisory Board: - 6 research offices (2 cancer treatment centers) - 2 non-labeled offices from other hospitals AP-HP (Saint-Louis) Hôpital FOCH Institut Curie CHS Sainte-Anne CH Versailles IGR DRCI CHU DRCI DRCI Autres 14 Missions of the Clinical Research Network in Paris Area (GIRCI ) Management of regional calls for clinical research projects News & education for all professionals involved in clinical research Support in all clinical research activities for investigators from nonuniversity-hospitals (without clinical research department) Assistance in implementation of some sponsor missions for nonuniversity-hospitals (pharmacovigilance, data monitoring ) Help investigators to reply to European calls for projects. 15 5

6 Activities achieved by the GIRCI IDF Management of regional calls in Support in clinical research activities for non-university-hospitals Ethical, legal, methodological, quality control advices For 39 hospitals in Region Assistance in implementation of some sponsor missions for nonuniversity-hospitals Quality assurance, pharmacovigilance, data monitoring Achieved by AP-HP & Gustave Roussy Institute for cancer res. For 14 hospitals in region Help to 20 investigators to reply to European calls for projects. 16 Ongoing activities of the GIRCI IDF Working group with Health Regional Agency Research organization in Region Mapping of potential enrollment of patients in clinical trials in hospitals Towards accreditation of professionals involved in clinical research Evaluation/improvement of knowledge using e-learning technologies Teaching portfolios in Region (courses, training practice ) Communication activities Active website Participation in local incentive campaigns Ambition: Clinical Research Home News & technical resources in Region 17 Clinical Research in AP-HP - Conclusion - AP-HP Internal clinical research network Strength : efficiency of decentralized CRU Weakness : complex relationships between structures Risk : time consuming procedures Opportunity : new regulation of European Parliament Regional clinical research network Strength : active participation of the CR offices Weakness : hospitals with different needs Risk : progressive exhaustion of the CR offices Opportunity : initial enthusiasm of the actors 18 6

7 Organisation des structures publiques de la recherche clinique en France 19 7