RT Journal Article
T1 Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.
A1 Serrano-Aguilar, Pedro
A1 Gutierrez-Ibarluzea, Iñaki
A1 Díaz, Pilar
A1 Imaz-Iglesia, Iñaki
A1 González-Enríquez, Jesús
A1 Castro, José Luis
A1 Espallargues, Mireia
A1 García-Armesto, Sandra
A1 Arriola-Bolado, Paloma
A1 Rivero-Santana, Amado
A1 Perestelo-Pérez, Lilisbeth
A1 González-Pacheco, Himar
A1 Álvarez-Pérez, Yolanda
A1 Faraldo-Vallés, María José
A1 Puñal-Riobóo, Janet
A1 Ramallo-Fariña, Yolanda
A1 Sánchez-Gómez, Luis María
A1 Asua-Batarrita, José
A1 Reviriego-Rodrigo, Eva
A1 Moreno-Rodríguez, Anai
A1 Juárez-Rojo, Celia
A1 Vicente-Saiz, Marisa
A1 Orejas-Pérez, Eugenia
A1 Knabe-Guerra, Jutta
A1 Prieto-Yerro, Isabel
A1 González Del Yerro-Valdés, Cristina
K1 Decision making
K1 Europe
K1 Postlaunch evidence-generation studies
K1 Real-world evidence
K1 Technology assessment
AB 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.
YR 2021
FD 2021-05-04
LK http://hdl.handle.net/10668/17739
UL http://hdl.handle.net/10668/17739
LA en
DS RISalud
RD Apr 17, 2025