Depuis plus de 15 ans, la plateforme BPE développe son expertise en pharmaco-épidémiologie, dans de nombreux domaines thérapeutiques, tant dans la réalisation d’études terrain avec un recueil de données prédéfinies, que dans la réalisation d’études sur bases de données préexistantes, en particulier celle de l’Assurance Maladie (en France : SNIIRAM, EGB, SNDS). Les résultats de ces études participent à la mise en place de recommandations pour optimiser les bénéfices et minimiser les risques des médicaments. Conformément à la charte de l’EnCePP, la plateforme BPE enregistre ses études sur le Registre de l’ENCePP.
De par son expérience et son expertise, l’équipe de la BPE conçoit, réalise, produit et valorise des études en pharmaco-épidémiologie.
Etudes SNDS
Analyse des données SNDS (Système National des Données de Santé)
Avec ses 15 ans d’expérience dans l’analyse et la gestion des données du Système national des données de santé ou SNDS (dont SNIIRAM, EGB), la BPE :
- A réalisé plus d’une cinquantaine d’études (cf. exemples ci-après)
- Dispose d’un « système fils » homologué selon les exigences du référentiel de sécurité SNDS
- A accès aux autres bases de données en Europe et aux USA (réseaux ENCePP, EU-ADR Alliance, Sigma)
- Participe à de nombreux projets internationaux multi-bases multi-pays
Etudes terrain
Depuis plus de 15 ans, la BPE réalise des études terrain :
- Études transversales / cohortes « médicament » ou « pathologie »
- Études cas-témoins
- Nombreux domaines thérapeutiques
- Mode de recueil adapté à la nature de l’étude : questionnaires médecin, pharmacien, patient, recueil à partir de dossiers médicaux, et différents outils (papier, e-crf, questionnaire téléphonique…)
- Process et circuits des données adaptés au volume des données
Nos études
| Cardiologie | Terrain | SNDS | ||
| ATHENA-F | Assessment of The High risk and unmEt Need in patients with coronary artery disease and type 2 diabetes in France |
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| ATTOS | Benefit and risk of AntiThrombotic Treatments after Orthopaedic Surgery in real-life settings: a cohort study in the SNIIRAM claims and hospitalisation database |
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| BROTHER | Benefit-Risk Of arterial THrombotic prEvention with Rivaroxaban for atrial fibrillation in daily clinical practice |
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| DEEPSPACE | Dual antiplatelet therapy for prolonged secondary prevention of acute coronary events |
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| ENGEL-1A | REal-life aNticoaGulants bEnefit-risk in atrial fibrilLation in France |
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| ENGEL-2 | REal-life aNticoaGulants comparative bEnefit-risk in nonvalvular atrial fibrillation (NVAF) in France |
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| EOLE | Observational study of post-myocardial infarction with a long follow-up |
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| HORUS | Health Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database |
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| IRAZU | Impact of cardiovascular comorbidities on the effectiveness of bevacizumab in elderly patients with metastatic colorectal cancer |
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| SPACE-AA | Secondary Prevention of Acute Coronary Events with Antiplatelet Agents: A cohort study in the SNIIRAM database |
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| Oncologie | Terrain | SNDS | ||
CAMERRA
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Therapeutic strategy in metastatic castration-resistant prostate cancer: target population and changes between 2012 and 2014. Two sequential cohorts within the French nation-wide claims and hospital database |
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FUJI
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Follow-Up of Jevtana® in real life
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| GROC | Glargine and risk of cancer |
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| Hépatotoxicité | Terrain | SNDS | ||
| EPIHAM | Epidemiology of acute hepatotoxicity from medicines |
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| SALT I | Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres |
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| SALT II | Study of Acute Liver Transplant-II |
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| SALT III | Study of Acute Liver Transplant-III: Prospective study of drug-exposed acute liver failure (ALF) in European liver transplant centers |
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| Performance, sécurité et étude d’utilisation | Terrain | SNDS | ||
| CASTHERM-Rhumato | Bénéfice d'une cure thermale à Castéra-Verduzan dans la gonarthrose |
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| DIORAMA | Resistant Depression in France, description from the nationwide claims and hospitalization database |
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| DUS
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Drug usage patterns of Pylera® in France using the national claims reimbursement database |
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| ECOLIFT | Economic evaluation of Prostatic Urethral Lift (Urolift) |
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| ECOREPAR | Economic evaluation of robot-assisted laparoscopic radical prostatectomy vs conventional laparoscopic radical prostatectomy and open retropubic radical prostatectomy in prostate cancer: a real-life study based on the French National Healthcare Data System (SNDS). |
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| ERAPP | Etude sur le Ressenti des Allergènes Préparés Spécialement pour un Individu (APSI) de la Part des Patients (pour nous contacter: etude.erapp@u-bordeaux.fr) |
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| EVIDEMS | Effectiveness of Tecfidera® in multiple sclerosis: a French cohort within the nationwide claims and hospital database |
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| EVORA | Assessment of Oralair® use in real-life |
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| INHALER | Real life assessment of chronic obstructive pulmonary disease Inhaler devices handling |
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SAPHARY
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A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study
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| USE-PACT | Use of Selincro® and impact on usual practice |
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| USSATHERM-Rhumato | Bénéfice d'une cure thermale à Ussat-les-Bains dans la lombalgie chronique |
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| USTEK | Etude observationnelle de sécurité post-AMM de l'ustekinumab et des autres traitements de la colite ulcéreuse à partir des données du Système National des Données de Santé (SNDS) |
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| LARYTHERM-Rhumato | Bénéfice dans la gonarthrose d’une cure thermale à Saint-Lary Soulan |
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| Multi bases Multi pays | Terrain | SNDS | ||
| BARICITINIB-RA | Comparative assessment of venous thromboembolism risk among patients with rheumatoid arthritis treated with baricitinib versus tumor necrosis factor inhibitors |
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| CAREME | Cardiovascular-Renal-Metabolism comorbidity epidemiology and healthcare utilisation |
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| EU-DOAC
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Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU |
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| GALCANEZUMAB | A retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care |
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| GBHF | Global burden of hip fractures - trends in incidence, post-fracture treatment, and mortality; a multi- country, observational study |
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| IV-IRON
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Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions |
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| MALBEC | Malignancies in Multiple Sclerosis: multi-country cohort database studies |
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| MINERVA | Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability |
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| OSTEOPOROSIS | Osteoporosis outcomes and treatment patterns in France |
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| ROMOSOZUMAB
(CV) |
European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance |
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| ROMOSOZUMAB
(RMM) |
European non-interventional post-authorization safety study related to adherence to the risk minimization measures for romosozumab by the EU-ADR alliance |
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| ROMOSOZUMAB
(SI) |
European non-interventional post-authorization safety study related to serious infections for romosozumab by the EU-ADR alliance |
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| VALSE | Valproate Stop and Switches: a cohort study to evaluate real world switching of valproate best practices for women of childbearing age in the SNDS French nationwide claims database |
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| Recherche en lien avec la COVID | Terrain | SNDS | ||
| ACCESS | ACCESS template protocol for safety of COVID-19 vaccines |
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| CONSIGN | COVID-19 infection and medicines in pregnancy - a multinational registry based study |
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| EVACOV-1 | Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines |
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| EVANESCO | Cohort event monitoring of COVID-19 vaccine safety in France using patient-reported outcomes |
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| Recherche en méthodologie* | Terrain | SNDS | ||
| ALCAPONE
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Alert generation using the case-population approach in the French claims databases |
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| ECOSTIM
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Budget impact analysis of discontinuing Tyrosin Kinase Inhibitors in patients with chronic myeloid leukemia achieving a complete molecular response by using probabilistic Markov approach |
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| CACIES | Nurses Internal Contamination by Antineoplastic Drugs |
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