Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making

• DOI: 10.1017/s0266462321000295
• Publication Date: 2021-05-04T09:21:12Z
• Authors: Pedro Serrano-Agu...; Iñaki Gutierrez-I...; Pilar Díaz; Iñaki Imaz-Iglesia; Jesús González-En...; José Luis Castro; Mireia Espallargues; Sandra García-Arm...; Paloma Arriola-Bo...; Amado Rivero-Santana; Lilisbeth Pereste...; Himar González-Pa...; Yolanda Álvarez-P...; María José Farald...; Janet Puñal-Riobóo; Yolanda Ramallo-F...; Luis María Sánche...; José Asua-Batarrita; Eva Reviriego-Rod...; Anai Moreno-Rodrí...; Celia Juárez-Rojo; Marisa Vicente-Saiz; Eugenia Orejas-Pérez; Jutta Knabe-Guerra; Isabel Prieto-Yerro; Cristina González...
• Keywords: Real-world evidence; Práctica clínica basada en la evidencia; Technology Assessment, Biomedical; Decision Making; Reproducibility of Results; Technology assessment; Postlaunch evidence-generation studies; Avalia-t; 3. Good health; Europe; Evaluación de la tecnología biomédica; 03 medical and health sciences; Spain; Costs and Cost Analysis; Humans; 0305 other medical science; Decision making; RedETS; toma de decisión

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.