from concept CLINICAL RESEARCH AT AP-HP:

Transcription

1 CLINICAL RESEARCH AT AP-HP: from concept to healthcare healthcare to Clinical Research and Development Department (DRCD) Ile-de-France Inter-Regional Clinical Research Organization (DIRC)

2 MISSIONS FACTS AND FIGURES INSTITUTIONAL SPONSORSHIP INDUSTRIAL SPONSORSHIP OPTIMISATION MISSION CLINICAL RESEARCH UNITS CLINICAL RESEARCH AND DEVELOPMENT DEPARTMENT (DRCD) ILE-DE-FRANCE INTER-REGIONAL CLINICAL RESEARCH ORGANIZATION (DIRC) MISSIONS MISSIONS The Clinical Research and Development Department (DRCD) is responsible for developing research at AP-HP and implementing all sponsorship regulations pursuant to the provisions of articles L et seq. of the French Public Health Code. In this context, it attends to the funding, implementation, supervision and quality control (monitoring) of research protocols sponsored by AP-HP. Due to the large number of research protocols managed or monitored by AP-HP, the DRCD created a number of clinical research units (Unités de recherche clinique - URC) for the decentralised management of some of its missions (methodological assistance, project monitoring, publishing assistance). Nine URC currently exist at AP-HP, based on the largest hospital sites (Pitié-Salpêtrière, Cochin Necker, Bichat, Bicêtre, H. Mondor, HEGP, A. Paré, Lariboisière Saint-Louis, Saint-Antoine), and managed by university hospital practitioners appointed by the sponsor s legal representative. Furthermore, two crossdisciplinary units also exist, linked to the DRCD or operating in connection with the department: the medical/economic unit and the clinical trials unit (unité d essais cliniques - UEC) of the AGEPS. The DRCD, which reports to the Medical Policy Division (Direction de la Politique Médicale - DPM), thus has a decentralised organization: it consists of a central body, located at Hôpital Saint-Louis, and decentralised clinical research units (URC). The DRCD also constitutes the Ile-de-France Inter-Regional Clinical Research Organization (DIRC), and is hence assigned the mission of leading clinical research with institutional sponsorship for all healthcare establishments in the Ile-de-France Region, particularly for establishments which have not set up a sponsorship body. THE DRCD IS ALSO RESPONSIBLE FOR THE FOLLOWING MISSIONS: Management of calls for projects Coordination of biological investigation and supervision of the use of biological resources Development of partnerships Exploitation of research and transfer Implementation of trials with industrial sponsorship Support for the design, management and monitoring of European projects

3 AP-HP: key figures 37 hospitals or hospital groups and home medical care program 3,908,500 consultations 1,107,500 short-term management cases 15,300 physicians In the AP-HP environment: 12 Federative Research Institutes 94 joint Inserm departments, units or research centresunits 19 CNRS research units 1 interventional imaging research centre with the INRA (CR2I) 5 CEA units FACTS AND FIGURES FACTS AND FIGURES Clinical research More than 2000 clinical research projects underway in 2008 within AP-HP, all sponsors combined. FACTS AND 797 research projects in progress (as of 31/05/2009), sponsored or managed by AP-HP, including 500 clinical trials with AP-HP institutional sponsorship. 30,875 patients included in AP-HP projects in 2008, with 17,251 patients included in clinical trials sponsored by AP-HP. 848 professionals dedicated to research and managed by the DRCD (as of 31/03/2009). 379 portfolios of active patents fi led. 591 registered biological sample collections More than 8,000 publications in Available to investigators 9 clinical research units (URC). 1 medical/economic URC. 1 AGEPS clinical trial pharmaceutical management unit. 16 clinical investigation centres (CIC). FIGURES 8 multiple-theme modules (CIC-P): Bichat, HEGP, Henri Mondor Albert Chenevier, Necker-Enfants Malades Cochin, Pitié-Salpêtrière, Robert Debré, Saint-Antoine, Saint-Louis. 4 biotherapy modules (CIC-BT): Cochin (vaccinology CIC), Henri Mondor, Necker-Enfants Malades - HEGP, Saint-Louis. 3 clinical epidemiology modules (CIC-EC): Bichat, HEGP, Robert Debré. 1 technological innovation module (CIC-IT): R. Poincaré 8 biomedical investigation centres (CIB): HOG (Haematology-Oncology- Transplants), PhenoGene, START (Saint-Antoine Trousseau Rothschild Tenon), Pitié-Salpêtrière, Paris-Sud, Créteil, Ouest, Cycle de la vie. AP-HP founding member of 4 themed research and healthcare networks and centres (CTRS/RTRS).

4 MISSIONS FACTS AND FIGURES INSTITUTIONAL SPONSORSHIP INDUSTRIAL SPONSORSHIP OPTIMISATION MISSION CLINICAL RESEARCH UNITS FACTS AND FIGURES FIGURES Partnerships FACTS AND > Research organizations (Inserm, CNRS, CEA, INRA, etc.). > 7 universities associated with AP-HP (including 7 faculties of medicine, 2 faculties of pharmacy and 2 faculties of dentistry). > Drug companies Leem. > Cancéropôle. > Medicen Paris Region biocluster. > Cooperative group (GELA, GERCOR, etc.). > Etablissement Français du Sang. > Institut Pasteur. > Associations (AFM, etc.). > Industrial partnership platforms (PPI) hosted by AP-HP: Haematology-oncology-transplants (Hôpital Saint-Louis) Motor and neurological disability (Hôpital Raymond Poincaré) Increased life expectancy (Hôpital Charles Foix) > Business incubators (Paris Biotech Santé, Paris Santé Cochin) FIGURES FIGURES

5 Main lines of research > Epidemiology, public health > Surgery > Clinical trials on medicinal products > Pathophysiology > Medical devices > Gene and cell therapy > Genetic studies > Practice assessment > Non-interventional research > Translational research > Rare diseases Fields of investigation: 8 thematic sectors within the Sponsorship Centre > Neuroscience, Neurology, Psychiatry > Genetics and Development > Cancer > Infectious diseases, Emergency, Intensive care > Circulation, Metabolism, Nutrition, Internal medicine > Immunology, Haematology, Pneumology > Public health > Health technology INSTITUTIONAL INSTITUTIONAL SPONSORSHIP SPONSORSHIP Sponsorship Centre The Sponsorship Centre is responsible for processing and monitoring clinical research projects sponsored or managed by AP-HP (DRCD). The Centre has a leadership and coordination role internally and as the interface with the clinical research units (URC). CONTACTS Projects sponsored by AP-HP Tel.: 33 (0) /17 76 Fax: 33 (0) /88 Calls for projects Tel.: 33 (0) /17 62 Fax: 33 (0) /88 info.drc@sls.aphp.fr SIGAPS drrc.sigaps-admin@sls.aphp.fr International Sponsorship Centre > International projects sponsored by AP-HP on an international scale. > Projects resulting from European calls for project, with funding from the European Commission (PCRD, DG Sanco, etc.). > Projects of an international nature as of inception, sponsored by AP-HP on a national scale. Centre for calls for projects > Management of external calls for projects (PHRC, STIC, translational research, PREQHOS, etc.). > Management of internal calls for projects (CRC, seed funds, etc.). > Management of calls for applicants (CNRS-CEA reception positions) > Processing of sponsorship applications other than calls for tenders > Scientific review of proposals Scientific Expert Review Commission (CES) 32 members Network of 1,800 experts.

6 MISSIONS FACTS AND FIGURES INSTITUTIONAL SPONSORSHIP INDUSTRIAL SPONSORSHIP OPTIMISATION MISSION CLINICAL RESEARCH UNITS INSTITUTIONAL SPONSORSHIP SPONSORSHIP Europe Unit Promoting AP-HP participation in calls for tenders by the European Commission: 1-7 th Research and Development Framework Programme FP 7 (DG Recherche) 2 - Health Programme (DG Sanco). Missions: > Information on programs implemented by the European Commission. > Encourage and facilitate the participation of teams and AP-HP research units in FP 7 and Sanco Programs. > Represent the institution in european and national working groups: Member of CLORA (Brussels), PCN Santé The National Working Group of the Ministery of Higher Education and Research > Assistance in setting up and negotiating projects (in cooperation with the European Commission and partner countries) Project management (negociation with the European Commission, partners countries, administrative and financial statements, follow up the project). > Project management (in collaboration with the European Commission and partner countries). > Guidance and support for hospitals responsible in charge of European projects. > Coordination and management of all the European projects in progress at AP-HP. Key figures: > Portfolio of 35 European projects. > AP-HP is leader of 5 European projects. Biological Resources and Bibliometric Indicators Centre > Legal and strategic advice on the use of human biological resources in research. > One-stop service for technical/regulatory procedures relating to biological resources. > Bibliometric unit (analysis of publications, SIGAPS management and user assistance). INSTITUTIONAL SPONSORSHIP

7 SIGAPS (Interrogation, Management and Analysis System for Scientific Publications) is a software dedicated to recording, evaluating and analysing scientific publications. Publications are downloaded from Pubmed and proposed for institutional practitioner validation. A qualitative score is calculated by taking into account the journal category (impact factor related by discipline) and the author s signature position. SIGAPS enables: - generation of lists of publications and indicators by person, department or hospital - consultation of the list of journals covered by Pubmed and their category in SIGAPS - consultation of the impact factors for journals available on JCR Web.

8 MISSIONS FACTS AND FIGURES INSTITUTIONAL SPONSORSHIP INDUSTRIAL SPONSORSHIP OPTIMISATION MISSION CLINICAL RESEARCH UNITS INDUSTRIAL INDUSTRIAL SPONSORSHIP SPONSORSHIP ONE-STOP SERVICE SPONSORSHIP One-stop service: Tel.: 33 (0) Fax: 33 (0) essais.industriels@sls.aphp.fr From proof-of-concept to phase IV studies > Medicinal products. > Medical devices > Cell therapies. Available to manufacturers > Harmonisation of methods for calculating hospital additional expenditures > Proposal of a single agreement for all AP-HP hospitals. > Inclusion mapping. > Corporate sponsor single invoicing. Key fi gures > More than 380 corporate sponsors work with AP-HP. > 130 CRO (contract research organizations). > 990 inclusion centres. > 305 hospital departments involved. > 350 new protocols per year. > 770 trials in progress as of 31/05/2009. CeNGEPS (National Centre for the Management of Trials on Healthcare Products) Contact Point of DIRC Ile-de-France The CeNGEPS is a public interest group which promotes more effective Organization of corporate-sponsored clinical trials, by: - Funding support actions for corporate-sponsored trials (calls for specific projects) - Providing investigators with dedicated staff (clinical study technicians) - Harmonising practices for setting up corporate-sponsored clinical trials and developing monitoring tools

9 OFFICE OF LICENSING AND TECHNOLOGY TRANSFER (OTT&PI) TRANSFER (OTT&PI) Office of licensing and technology transfer Tel.: 33 (0) /17 74 Fax: 33 (0) Linked to the DRCD, the OTT&PI protects and optimizes innovations resulting from hospital care and research by AP-HP clinical departments, laboratories and teams (clinical practitioners, nursing staff, managers, etc.). Providing dynamic support for innovation initiators, and personnel with special expertise, the OTT&PI establishes preferential partnerships with French and international medical and biomedical firms and other research organizations in order to create optimum conditions for marketing innovative products and services ultimately to be used by patients. APINNOV: yearly AP-HP technology transfer meeting Organised in partnership with regional economic protagonists since 2003, this annual event proposes AP-HP innovations to French companies in the field of health, in a business meeting setting. Key figures > 379 international portfolios of active patents. > 130 active licences > 460 research collaboration and industrial partnerships agreements. > 28 firms resulting from AP-HP innovations. Missions > Sourcing and protecting innovations generated by AP-HP personnel. > Technology transfer. > Creation of research collaboration agreements. > Incentives for partnerships with manufacturers on certain hospital sites. > Promoting business creation based on AP-HP innovations. > Raising awareness and training teams in the challenges involved in protecting innovation.

10 MISSIONS FACTS AND FIGURES INSTITUTIONAL SPONSORSHIP INDUSTRIAL SPONSORSHIP OPTIMISATION MISSION CLINICAL RESEARCH UNITS YOUR R&D PARTNER YOUR R&D PARTNER FROM CONCEPT TO IMPLEMENTATION OF YOUR CLINICAL RESEARCH PROJECT Pre-trial > Feasibility study > Assistance in patient recruitment > Protocol design > Methodological and administrative assistance > Organization of contacts with investigators, scientific teams and CIC > Budgeting withdrcd department input > Recruitment and training of dedicated shared personnel: mainly TEC (clinical study technicians) and ARC (clinical research assistants) Per-trial > Project quality control (monitoring) delegated by the AP-HP sponsor (DRCD) > Contact with investigators > Coordination with the associated scientific teams, technical resources, medical laboratories > TEC provision on site: to facilitate patient recruitment to improve the quality of data acquisition > ARC intervention on site for quality control > Monitoring of trial progress > Newsletter writing Post-trial > Data entry > Statistical analysis > Article co-authoring

11 CLINICAL RESEARCH UNITS Units dedicated to clinical research, providing logistic and methodological support CLINICAL RESEARCH UNITS MISSIONS > Stimulating clinical research at AP-HP > Organising multicentre clinical trials MISSIONS > Ensuring quality control (monitoring) and follow-up of AP-HP research projects > Providing methodological and logistic assistance for research project implementation

12 Clinical Research Units (URC) Bichat - Beaujon Saint-Louis - Lariboisière Etablissements rattachés > Bichat Claude Bernard > Beaujon > Robert Debré > Louis Mourier > Bretonneau > Lariboisière > Saint-Louis > Fernand Vidal > Avicenne > Jean Verdier > Charles Richet > René Muret Médecin coordonnateur Coordonnées Secrétariat Adresses Dr Florence TUBACH florence.tubach@bch.aphp.fr Secrétariat: Catherine GILLET Tel.: sec.debrc@bch.aphp.fr Pr Eric VICAUT Secrétariat: Michèle AGOR Tel.: sec.urc@lrb.aphp.fr Pr Sylvie CHEVRET sylvie.chevret@univ-paris-diderot.fr Secrétariat: Sabrina DUBIEF Tel.: sec.dbim@univ-paris-diderot.fr Groupe Bichat-Claude Bernard 46, rue Henri Huchard Paris Hôpital Fernand Widal Bâtiment François Rabelais 200, rue du Faubourg Saint-Denis Paris Hôpital Saint-Louis - Pavillon Lailler Service du DBIM - secteur bleu - porte 4 1, avenue Claude Vellefaux Paris Cedex 10 Bicêtre - P Brousse > Bicêtre > Paul Brousse > Antoine Béclère Pr Laurent BECQUEMONT laurent.becquemont@bct.aphp.fr Secrétariat: Séverine BREMONT Tel.: severine.bremont@bct.aphp.fr CHU de Bicêtre Cour de Sibérie, porte 105, 78, rue du Général Leclerc Le Kremlin Bicêtre Mondor > Henri Mondor > Albert Chenevier > Emile Roux > CHI Créteil (Hors AP-HP) Dr Patrick MAISON patrick.maison@hmn.aphp.fr Secrétariat: Sylvie GAMBUCCI Tel.: sylvie.gambucci@hmn.aphp.fr CHU Henri Mondor 51, Avenue du Maréchal de Lattre de Tassigny Créteil Cedex HEGP > HEGP > Broussais Pr Gilles CHATELLIER gilles.chatellier@egp.aphp.fr Secrétariat: Angeline COURQUIN Tel.: (demandez le poste 12075) angeline.courquin@egp.aphp.fr URC - Hôpital Européen Georges Pompidou 20-40, rue Leblanc Paris Cedex 15 R Poincaré - A Paré > Raymond Poincaré - Berck > Ambroise Paré > Hendaye - San-Salvadour > Sainte-Périne-Chardon Lagache > C.H.I.P.S (Hors AP-HP) > CMC Foch (Hors AP-HP) > CH André Mignot (Hors AP-HP) Dr Philippe AEGERTER Tél. : philippe.aegerter@apr.aphp.fr Hôpital Ambroise Paré 9, avenue Charles de Gaulle Boulogne Necker > Cochin > Saint-Vincent de Paul > Broca-La Roche Foucauld > Hôtel-Dieu > Necker > Corentin Celton > Vaugirard > CH Sainte-Anne (Hors AP-HP) > Saint-Joseph (Hors AP-HP) Pr Jean-Marc TRELUYER jm.treluyer@svp.aphp.fr Secrétariat: Mme MAINIER Tel.: secretariat.urc@cch.aphp.fr Hôpital Necker Enfants Malades 149, rue de Sèvres Secteur Orange - Porte Paris Cedex 15

13 Clinical Research Units (URC) Cochin - Hôtel-Dieu Etablissements rattachés > Cochin > Saint-Vincent de Paul > Broca-La Roche Foucauld > Hôtel-Dieu > Necker > Corentin Celton > Vaugirard > CH Sainte-Anne (Hors AP-HP) > Saint-Joseph (Hors AP-HP) Médecin coordonnateur Pr Jean-Marc TRELUYER Coordonnées Secrétariat Adresses jm.treluyer@svp.aphp.fr Secrétariat: Mme MAINIER Tel.: secretariat.urc@cch.aphp.fr URC Cochin Port-Royal - Site Tarnier 89, rue d Assas Paris STARTT (Saint-Antoine, Rothschild, Tenon, Trousseau) > Saint-Antoine > Rothschild > Tenon > Armand Trousseau > CHNO Quinze Vingts (Hors AP-HP) > Groupe Diaconesses - la Croix Saint-Simon (Hors AP-HP) Pr Tabassome SIMON Dr Valérie ACAR Serge BUREAU responsable fi nancier et administratif urcest@chusa.jussieu.fr valerie.acar@sat.aphp.fr serge.bureau@sat.aphp.fr Secrétariat: Valérie DOGBO Tel.: valerie.dogbo@sat.aphp.fr Hôpital Saint-Antoine 184, rue du Faubourg Saint-Antoine Paris cedex 12 Pitié-Salpêtrière > Pitié-Salpêtrière > Charles Foix - Jean Rostand > Joffre Dupuytren Pr Alain MALLET alain.mallet@psl.aphp.fr Secrétariat: Martine POMMIER Tel.: martine.pommier@psl.aphp.fr Hôpital de la Pitié-Salpêtrière Pavillon Mazarin 47-83, Boulevard de l Hôpital Paris Avicenne - J Verdier > Avicenne > Jean Verdier > René Muret - Bigottini Pr Vincent LEVY Tel.: vincent.levy@avc.aphp.fr Standard: Tel.: Hôpital Avicenne - Université Paris 13 Pôle Hématologie Oncologie Thorax 125, Route de Stalingrad Bobigny Unité transversale thématique s adressant à l ensemble des investigateurs d Ile-de-France URC Eco - L unité de Recherche Clinique en Economie de la Santé d Ilede-France Pr Isabelle DURAND-ZALESKI Dr Karine CHEVREUL Tel.: isabelle.durand-zaleski@hmn. aphp.fr karine.chevreul@hmn.aphp.fr 228, Rue du Faubourg Saint-Martin PARIS UEC de l AGEPS Unité de Gestion Pharmaceutique des Essais Cliniques Institutionnels (UGPECI) Mme Annick TIBI Secrétariat: Elisabeth RODRIGUEZ Tel.: secretariat.sec@eps.aphp.fr 7, Rue du Fer à Moulin PARIS

14 FULL INFORMATION AVAILABLE ON THE WEBSITE > Respond to calls for tenders > Request AP-HP sponsorship > Download practical documents > Contact the one-stop service - corporate-sponsored trials > Contact the AP-HP research units (URC, CIC, CIB, etc.) > Contribute to a clinical trial > Consult: AP-HP sponsorships publications letter from the Clinical Research and Development Department Direction de la Politique Médicale Département de la Recherche Clinique et du Développement (DRCD) Délégation Interrégionale à la Recherche Clinique (DIRC Ile-de-France) Hôpital Saint-Louis Carré Historique porte 23 1, Avenue Claude Vellefaux PARIS Accueil téléphonique direction : Conception : l exprimeur YD Print imprimé sur papier PEFC Coming soon: new version of the website