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Therapie. 2018 Feb;73(1):13-24. doi: 10.1016/j.therap.2017.12.008. Epub 2017 Dec 30.

Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases.

Author information

Service de pharmacologie médicale, CHU de Bordeaux, 33076 Bordeaux, France.
AstraZeneca France, Tour Carpe Diem, 92400 Courbevoie, France. Electronic address:
Johnson & Johnson Medical, 92130 Issy-les-Moulineaux, France.
Haute Autorité de Santé, 93218 Saint-Denis-la-Plaine, France.
Medtronic France, 92513 Boulogne-Billancourt, France.
AFCROs & Axonal-Biostatem, 92024 Nanterre, France.
Johnson & Johnson - Janssen Cilag, 92130 Issy-les-Moulineaux, France.
Université de Lille, CHRU de Lille, EA 2694 "Santé publique : épidémiologie et qualité des soins", 59000 Lille, France.
Bristol-Myers Squibb France, 92500 Rueil-Malmaison, France.
SFPT, CHU hôpital Bretonneau, 37044 Tours, France.
Délégation à la Recherche Clinique et à l'Innovation, Assistance Publique des Hôpitaux de Paris, 75010 Paris, France.
Exepi, 75008 Paris, France.
Sanofi, 75008 Paris, France.
Helsia, 75008 Paris, France.
Bordeaux PharmacoEpi, Université de Bordeaux, 33076 Bordeaux, France.
GlaxoSmithKline France, 92500 Rueil-Malmaison, France.
R&D Unicancer, 75013 Paris, France.
3M France, 95006 Cergy-Pontoise, France.
Comité Économique des Produits de Santé, 75350 Paris, France.
Inserm UMR 1219, Université de Bordeaux & CHU de Bordeaux, 33000 Bordeaux, France.


Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database. These databases, although developed for other purposes, have already been used for many years with regard to post-registration studies (PRS). The use thereof will continue to increase with the recent creation of the French National Health Data System (SNDS [2016 health system reform law]). At the same time, other databases are available in France, offering an illustration of "product use under actual practice conditions" by patients and health professionals (cohorts, specific registries, data warehouses, etc.). Based on a preliminary analysis of requests for PRS, approximately two-thirds appeared to have found at least a partial response in existing databases. Using these databases has a number of disadvantages, but also numerous advantages, which are listed. In order to facilitate access and optimise their use, it seemed important to draw up recommendations aiming to facilitate these developments and guarantee the conditions for their technical validity. The recommendations drawn up notably include the need for measures aiming to promote the visibility of research conducted on databases in the field of PRS. Moreover, it seemed worthwhile to promote the interoperability of health data warehouses, to make it possible to match information originating from field studies with information originating from databases, and to develop and share algorithms aiming to identify criteria of interest (proxies). Methodological documents, such as the French National Authority for Health (HAS) recommendations on "Les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes). Principes et méthodes" [Post-registration studies on health technologies (medicinal products, medical devices and procedures). Principles and methods] should be updated to incorporate these developments.


Actual practice data; Databases; Health technologies assessment; Pharmacoepidemiology; Post-registration study; SNDS

[Indexed for MEDLINE]

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