Clinical research at AP-HP (Paris Public Hospitals)

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1 Clinical research at AP-HP (Paris Public Hospitals)

2 Clinical research at AP-HP A strict regulatory framework (biomedical research) a sponsor in the sense of the French Public Health Code opinion of a Committee for the Protection of Persons (CPP) authorisation by the National Agency for the Safety of Pharmaceuticals and Health Products (ANSM) Substantial financial resources: calls for projects external: ministries, institutions (Inserm, INCa, ANR,...), Europe, Regions, industrialists internal: AP-HP financing Rigorous scientific assessment National committees Scientific expertise commission (SEC) of AP-HP A structured organisation Clinical Research and Development Department (CRDD) Clinical research units (CRU's) Hospital groups (HG)

projects external: ministries, institutions (Inserm, INCa, ANR,.

3 Clinical research at AP-HP: a structured organisation Sponsoring activity: the Clinical Research and Development Department (CRDD) and the clinical research units (CRU's) Missions of the CRDD: perform the missions and duties of the SPONSOR AP-HP: administrative, civil, and penal responsibilities, technical and regulatory project management, relations with the competent authorities - ANSM - and the CPP's, assessment and control of the monitoring performed by the CRU's, supervision of the trials, management and budgetary control in addition to human resources management of the projects, quality assurance and audits, develop promotion and industrial and institutional partnerships while defending the interests of AP-HP, supportive activities: human resources management, financial management, training in clinical research,... Mission of the CRU's: 12 CRU's exist (1 per HG): consultancy and methodological assistance, preparation of the application files in response to calls for projects, monitoring and quality control of the research protocols (by delegation and under the responsibility of the sponsor - CRDD), support in data acquisition, technical and regulatory assistance, administrative management in liaison with the HG departments in question (HR, Finance) and the CRDD head office, training in clinical research, Missions of the HG: management of the investigation support structures: Clinical investigation centres (CIC), Clinical research centres (CRC), Biological resource centres (BRC), tumour libraries, Biomedical investigation centre (BIC),... Establish and coordinate the administrative management units for research of the HG, act as an interface among the functional departments of the HG's, CRU's and the CRDD head office Mobilise the investigators

and the CPP's, assessment and control of the monitoring performed by the CRU's, supervision of the trials, management and budgetary control in addition to human resources management of the projects,

4 CLINICAL RESEARCH STRUCTURES within AP-HP Staff specifically devoted to the research activities (CRDD): 918 full-time equivalents

5 Clinical research at AP-HP: the AP-HP "research environment" 7 associated universities 7 faculties of medicine 2 faculties of the pharmacy 2 faculties of odontology 73 Inserm units, 15 CNRS units, 1 CEA unit,1 Inra unit 17 Clinical investigation centres (CIC's) 4 Clinical research centres (CRC's) 12 Biological resource centres (BRC's) 14 tumour libraries 4 Research topic centres/networks (RTC/N's) 7 federative research institutes (FRI's) 4 CTRS/RTRS (Imagine, Prem up, Fondamental, Centaure) 3 Teaching hospital institutes (THI's Imagine, ICAN, A-ICM) 16 Teaching hospital departments (THD's) MEDICEN Paris region competitiveness cluster "Paris Biotech Santé" (Cochin) business incubator and seedbed

libraries 4 Research topic centres/networks (RTC/N's) 7 federative research institutes (FRI's) 4 CTRS/RTRS (Imagine, Prem up, Fondamental, Centaure) 3 Teaching hospital

6 Clinical research at AP-HP: key figures 917 research projects with AP-HP sponsorship or management in progress in ,604 patients included in interventional research projects sponsored or managed by AP-HP 1452 projects with industrial sponsorship in progress within AP-HP in 2013, involving 329 different industrial sponsors some 600 research projects with academic or institutional sponsorship (outside AP-HP), involving 56 different academic sponsors (teaching hospital centres, anticancer centres, research bodies, ) I.e. more than 3000 research projects, all sponsors considered together, in progress within AP-HP in 2013 Staff specifically devoted to the research activities (CRDD): 918 full-time equivalent 9330 scientific publications recorded in SIGAPS in 2013 were signed by at least one AP-HP author, i.e. more than 40% of French hospital publications 487 portfolios of active patents and 192 active licences Success rate of more than 30% in the ministerial calls for projects (including 38% of national hospital clinical research programmes) Ministerial financing of the teaching, research, reference and innovation missions (TRRI) in 2013: 750 M (i.e. 26% of the national envelope)

7 Clinical research at AP-HP: key thematic areas

8 Clinical research at AP-HP: typology of the calls for projects Calls for projects with external funding Ministry of health (Health insurance credits): National and interregional hospital clinical research program (HCRP) Medico-economic research programme (MERP) Research programme on performance of the heathcare system (RPPHS) Nursing and paramedical hospital research programme (NPHRP) Translational research programme (TRP) "Researcher" interface contracts (call for applications) State: National institute of health and medical research (Inserm) National research agency (ANR) National cancer institute (INCa) Competitiveness clusters Local communities: Regions Municipality European Commission: Framework research and development programme (FRDP) Directorate General for Health and Consumers (DG SANCO)

Translational research programme (TRP) "Researcher" interface contracts (call for applications) State: National institute of health and medical research (Inserm) National research agency (ANR)

9 Clinical research at AP-HP: typology of the calls for projects Calls for projects with internal funding Clinical research contracts (CRC's) more than 20 projects funded in 2013 more than 1.5 M of funding allocated in 2013 Complementary medicine 4 projects chosen in ,000 of funding allocated in 2013 Joint call to tender Institut Pasteur/AP-HP, Calls for applications Host positions (AP-HP, Institut Pasteur, Ecole polytechnique, CNRS, CEA, National Higher School of Arts and Crafts (ENSAM), Compiègne university of technology, City of Paris Industrial Physics and Chemistry Higher Educational Institution (ESPCI), LabexBiopsy): 22 applicants, 13 award recipients in 2013 Doctorate in "Nursing research": 4 candidates, 1 award recipient Doctorate in "Midwifery research": 3 candidates, 2 award recipients Sponsorship "outside the call to tender process" funding obtained outside calls to tender allowing coverage of the entire outlay project expertise by the SEC analysis of project feasibility

positions (AP-HP, Institut Pasteur, Ecole polytechnique, CNRS, CEA, National Higher School of Arts and Crafts (ENSAM), Compiègne university of technology, City of Paris Industrial Physics and

10 Clinical research at AP-HP: Complementary medicine and traditional Chinese medicine 15 ongoing projects (1.97 M ) : Five projects in traditional chinese medicine (including 3 in acupuncture) > funding amounting to 976,000 8 projects in complementary medicine funding amounting to 1 M AP-HP internal calls for projects in 2012: specific axis of "Complementary medicine and traditional Chinese medicine" Aim: projects in traditional Chinese medicine conducted jointly with centres in China (Hong Kong, Canton, Shanghai, Nanking + Peking)

complementary medicine funding amounting to 1 M AP-HP internal calls for projects in 2012: specific axis of "Complementary medicine

THE FRENCH HEALTH SYSTEM. Yann Bubien. University Hospital General Director, Angers

THE FRENCH HEALTH SYSTEM. Yann Bubien. University Hospital General Director, Angers THE FRENCH HEALTH SYSTEM Yann Bubien University Hospital General Director, Angers 1 INTRODUCTION International studies have confirmed that France has one of the best-performing healthcare systems in the