Please use this identifier to cite or link to this item:http://hdl.handle.net/20.500.12105/14545
Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making
Serrano-Aguilar, Pedro | Gutierrez-Ibarluzea, Iñaki | Díaz, Pilar | Imaz-Iglesia, Iñaki ISCIII | Gonzalez-Enriquez, Jesus ISCIII | Castro, José Luis | Espallargues, Mireia | García-Armesto, Sandra | Arriola-Bolado, Paloma | Rivero-Santana, Amado | Perestelo-Pérez, Lilisbeth | González-Pacheco, Himar | Álvarez-Pérez, Yolanda | Faraldo-Vallés, María José | Puñal-Riobóo, Janet | Ramallo-Fariña, Yolanda | Sanchez-Gomez, Luis Maria ISCIII | Asua-Batarrita, José | Reviriego-Rodrigo, Eva | Moreno-Rodríguez, Anai | Juárez-Rojo, Celia | Vicente-Saiz, Marisa | Orejas-Pérez, Eugenia | Knabe-Guerra, Jutta | Prieto-Yerro, Isabel | González Del Yerro-Valdés, Cristina
Int J Technol Assess Health Care. 2021 May 4;37(1):e63.
The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.
Decision making | Europe | Postlaunch evidence-generation studies | Real-world evidence | Technology assessment
Artículos galardonado con el Premio al Mejor Artículo Científico de 2021 publicado en la revista oficial de la Health Technology Assessment international (HTAi).
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