Last updated on: 22/07/2015
Name of organisation
1) Department/Research groupCentre de pharmaco-épidémiologie
2) Organisation/affiliationAssistance Publique - Hôpitaux de Paris
Short Name in the inventoryParis Pharmacoepidemiology Centre
Administrative Contact
Title Professor
Last name Le Louët
First name Hervé
Address line 1Pharmacovigilance and risk management department
Address line 2Henri Mondor University Hospital
Address line 351 avenue du Maréchal de Lattre de Tassigny
CityCréteil Cédex
Postcode94010
CountryFrance
Phone number (incl. country code)33149814702
Alternative phone number
Fax number (incl. country code)33149814763
Scientific Contact
Title Professor
Last name Tubach
First name Florence
Address line 1Clinical investigation and epidemiology centre (CIE 801)
Address line 2Bichat University Hospital
Address line 346 rue Henri Huchard
CityParis Cedex 18
Postcode75877
CountryFrance
Phone number (incl. country code)33140257941
Alternative phone number
Fax number (incl. country code)33140256773
2. Description
The Paris academic pharmacoepidemiology centre associates the Bichat hospital’s clinical investigation and epidemiology centre (INSERM CIE 1425) and the H. Mondor hospital’s pharmacovigilance department.
The centre aims at:
• assessing health care interventions (drugs, devices …) in real conditions of utilisation in the context of academic issues or RMPs: utilisation pattern, benefice/risks
• developing methodological research
We carry out cohort studies, RCT, surveys, …, as well as using pharmacovigilance or health insurance DB.
The centre is based in AP-HP, a network of 43 hospitals comprising 6 millions patients and 13 000 physicians (most of them experts at the national or international level). This configuration represents a real opportunity for developing large-scale studies.
The centre is represented at the board of CIOMS, ISOP (presidency), PRAC and Eudravigilance WG.
Research with European patient associations and Sociologic dpt of Universities of North Europe is planned
3. Category
University based
Hospital based
4. Available resources
In houseVia Contacts/Network
Project management (epidemiology and clinical research unit)
Yes
No
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Anaesthesia
Cardiovascular diseases
Devices
Disorders of the central nervous system
Ear, nose and oropharynx disorders
Endocrine disorders
Gastrointestinal tract
Geriatrics
Immunological products and vaccines
Immunosuppression
Infectious diseases
Liver disease
Malignant disease
Musculoskeletal and joint diseases
Nutrition and blood
Pregnancy
Respiratory diseases
Skin disorders
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
Drug Utilisation
Interventional Clinical Trial
Meta-Analysis
Registry
Cross-sectional study
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Greater than 5
Number of patients/respondents involved in the study(ies)
Less than 150
Between 150 and 1499
Between 1500 and 14999
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
Yes
System used:
eCRF, digital pens
Interactive voice response systems
No
Call centre
Yes
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
National Pharmacovigilance Database12
EGB1
Air PR1
Cristal1
11. Registries established by centre
Drug RegistryDevices, TNF alpha inhibitors
Disease RegistryCardiovasculare diseases, SUSAC syndrome, Pregnancy, Elderly
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
Psonet
RegiSCAR
Other networks:
Network nameNationalInternationalLink to webpage
French CIC Network
Yes
No
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Lansac E, Bouchot O, Arnaud Crozat E, Hacini R, Doguet F, Demaria R, Leguerrier A, Jouan J, Chatel D, Lopez S, Folliguet T, Acar C, Leprince P, Langanay T, Jegaden O, Bessou JP, Albat B, Latremouille C, Fabiani JN, Fayad G, Fleury JP, Pasquet B, Debauchez M, Di Centa I, Tubach F. Standardized approach to valve repair using an expansible aortic ring versus mechanical Bentall: Early outcomes of the CAVIAAR multicentric prospective cohort study. The Journal of thoracic and cardiovascular surgery. Feb 2015;149(2 Suppl):S37-45.
Roussel R, Hadjadj S, Pasquet B, Wilson PW, Smith SC, Jr., Goto S, Tubach F, Marre M, Porath A, Krempf M, Bhatt DL, Steg PG. Thiazolidinedione use is not associated with worse cardiovascular outcomes: a study in 28,332 high risk patients with diabetes in routine clinical practice: brief title: thiazolidinedione use and mortality. International journal of cardiology. Aug 20 2013;167(4):1380-1384.
Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: A multicenter randomized controlled trial. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases. Feb 2015;21(2):180 e181-187.
Mourvillier B, Tubach F, van de Beek D, Garot D, Pichon N, Georges H, Lefevre LM, Bollaert PE, Boulain T, Luis D, Cariou A, Girardie P, Chelha R, Megarbane B, Delahaye A, Chalumeau-Lemoine L, Legriel S, Beuret P, Brivet F, Bruel C, Camou F, Chatellier D, Chillet P, Clair B, Constantin JM, Duguet A, Galliot R, Bayle F, Hyvernat H, Ouchenir K, Plantefeve G, Quenot JP, Richecoeur J, Schwebel C, Sirodot M, Esposito-Farèse M, Le Tulzo Y, Wolff M. Induced hypothermia in severe bacterial meningitis: a randomized clinical trial. JAMA. 2013 Nov 27;310(20):2174-83.
Sbidian E, Eftekahri P, Viguier M, Laroche L, Chosidow O, Gosselin P, Trouche F, Bonnet N, Arfi C, Tubach F, Bachelez H. National Survey of Psoriasis Flares after 2009 Monovalent H1N1/Seasonal Vaccines. Dermatology (Basel, Switzerland). 2014;229(2):130-135.
