Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases
| Autor: | Mathieu Robain, Nicholas Moore, Benoît Dervaux, Denis Comet, Philippe Lechat, Florence Thomas-Delecourt, Christophe Roussel, Véronique Lamarque-Garnier, André Tanti, Karine Szwarcensztein, Cécile Déal, Hubert Méchin, Anne-Françoise Gaudin, Sébastien Marque, Philippe Maugendre, Anne d’Andon, Frantz Thiessard, Gaëlle Nachbaur, Cécile Collignon, Driss Berdaï |
|---|---|
| Přispěvatelé: | Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Interoperability
Market access 030501 epidemiology computer.software_genre 030226 pharmacology & pharmacy Field (computer science) 03 medical and health sciences 0302 clinical medicine Order (exchange) Information system Product Surveillance Postmarketing Humans Pharmacology (medical) PharmacoEpi-Drugs Database ERIAS Pharmacoepidemiology Health technology Data warehouse 3. Good health Product (business) Databases as Topic [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie Business France 0305 other medical science computer |
| Zdroj: | Thérapie Thérapie, EDP Sciences, 2018, 73 (1), pp.13-24. ⟨10.1016/j.therap.2017.12.008⟩ |
| ISSN: | 0040-5957 1958-5578 |
| DOI: | 10.1016/j.therap.2017.12.008⟩ |
| Popis: | 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 etudes post-inscription sur les technologies de sante (medicaments, dispositifs medicaux et actes). Principes et methodes" [Post-registration studies on health technologies (medicinal products, medical devices and procedures). Principles and methods] should be updated to incorporate these developments. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|