Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making. (4th May 2021)

• Record Type: Journal Article
• Authors: Serrano-Aguilar, Pedro; Gutierrez-Ibarluzea, Iñaki; Díaz, Pilar; Imaz-Iglesia, Iñaki; González-Enríquez, Jesús; 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; Sánchez-Gómez, Luis María; 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
• Is Part Of: International journal of technology assessment in health care. Volume 37:Number 1(2021)
• Publication Date: 2021-05-04
• Subjects: Technology assessment, -- Postlaunch evidence-generation studies, -- Real-world evidence, -- Decision making, -- Europe; Medical technology -- Periodicals; Technology assessment -- Periodicals; 610.28
• DOI: 10.1017/S0266462321000295
• Languages: English
• ISSNs: 0266-4623

Abstract

Abstract: 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.