Overview of French databases available for studying anticancer drugs in real-life setting

被引:8
作者
Casarotto, Emilie [1 ,2 ]
Noize, Pernelle [1 ,3 ]
Gouverneur, Amandine [1 ,3 ]
Berdai, Driss [3 ]
Begaud, Bernard [1 ]
Levy-Bachelot, Laurie [2 ]
Molimard, Mathieu [1 ,3 ]
机构
[1] Univ Bordeaux, INSERM, BPH, U1219, F-33000 Bordeaux, France
[2] MSD France, F-92800 Puteaux La Defense, France
[3] CHU Bordeaux, Serv Pharmacol Med, Pole Sante Publ, F-33000 Bordeaux, France
关键词
antineoplastic agents; database; post-marketing; product surveillance; METASTATIC COLORECTAL-CANCER; TARGETED THERAPIES; PROSTATE-CANCER; PHARMACOVIGILANCE; INHIBITORS; FRANCE; SYSTEM; SNIIRAM; REGION;
D O I
10.1111/fcp.12592
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Considering their novelty and cost, post-marketing evaluation is highly relevant for new anticancer drugs. Identify and characterize available and potentially useful databases for post-marketing evaluation of these specific drugs is necessary. A review was conducted to identify available and accessible databases to study the post-marketing evaluation of drugs in real-life care setting. Databases identified have been classified into medico-administrative databases, medical record databases, and databases resulting from ad hoc collections. Taking as examples databases available in France, each type was described as well as its strengths and limits for a potential use in the oncology field. Record linkage of medico-administrative databases could cover almost the whole population and is now used to evaluate anticancer drugs (e.g., Systeme National des Donnees de Sante). Large medical record databases are still lacking, but efforts are currently made to give access to hospital data warehouses for research purposes. Finally, databases resulting from ad hoc collections are also available for some cancer localizations and allow to obtain highly valuable clinical and biological data. A range of important and valuable databases exist but, individually, none is enough to answer to all questions from health authorities, healthcare professionals, and patients. In order to obtain a complete overview on utilization, associated health outcomes and costs of these drugs, it seems necessary to better interlink available databases.
引用
收藏
页码:76 / 85
页数:10
相关论文
共 52 条
[1]  
Adenot I., 2007, Annales Pharmaceutiques Francaises, V65, P325, DOI 10.1016/S0003-4509(07)92595-X
[2]   Evaluation of algorithms to identify incident cancer cases by using French health administrative databases [J].
Ajrouche, Aya ;
Estellat, Candice ;
De Rycke, Yann ;
Tubach, Florence .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 (08) :935-944
[3]   Empirical estimation of under-reporting in the US Food and Drug Administration Adverse Event Reporting System (FAERS) [J].
Alatawi, Yasser M. ;
Hansen, Richard A. .
EXPERT OPINION ON DRUG SAFETY, 2017, 16 (07) :761-767
[4]   Pharmacovigilance Assessment of Immune-Mediated Reactions Reported for Checkpoint Inhibitor Cancer Immunotherapies [J].
Ali, Ayad K. ;
Watson, David E. .
PHARMACOTHERAPY, 2017, 37 (11) :1383-1390
[5]   Rates of spontaneous reporting of adverse drug reactions in France [J].
Bégaud, B ;
Martin, K ;
Haramburu, F ;
Moore, N .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2002, 288 (13) :1588-1588
[6]  
Begaud B., 1998, DICT PHARM EPIDEMIOL, P190
[7]  
Begaud B., DONNEES VIE REELLE E
[8]   The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology [J].
Bezin, Julien ;
Duong, Mai ;
Lassalle, Regis ;
Droz, Cecile ;
Pariente, Antoine ;
Blin, Patrick ;
Moore, Nicholas .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 (08) :954-962
[9]   National trends in use and costs of oral anticancer drugs in France: An 8-year population-based study [J].
Bosco-Levy, Pauline ;
de Boissieu, Paul ;
Gouverneur, Amandine ;
Noize, Pernelle ;
Molimard, Mathieu ;
Fourrier-Reglat, Annie ;
Bezin, Julien .
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 (10) :1233-1241
[10]  
Bousquet P.J., 2018, PLOS ONE, P13