Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.
Int J Technol Assess Health Care
; 37(1): e63, 2021 May 04.
Article
en En
| MEDLINE
| ID: mdl-33942712
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.
Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Evaluación de la Tecnología Biomédica
/
Toma de Decisiones
Tipo de estudio:
Health_economic_evaluation
/
Health_technology_assessment
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Int J Technol Assess Health Care
Asunto de la revista:
PESQUISA EM SERVICOS DE SAUDE
Año:
2021
Tipo del documento:
Article