A framework for monitoring of new drugs in Sweden.
Ups J Med Sci
; 124(1): 46-50, 2019 Jan.
Article
en En
| MEDLINE
| ID: mdl-30689485
ABSTRACT
In order to monitor the net public health benefit of new drugs, especially in the light of recent stepwise approval approaches, there is a need to optimize real-time post-marketing evaluation of new drugs using data collected in routine care. Sweden, with its unique possibilities for observational research, can provide these data. We herein propose a framework for continuous monitoring of the effectiveness, safety, and cost-effectiveness of new drugs, using prospectively determined protocols designed in collaboration between all relevant stakeholders. We believe that this framework can be a useful tool for healthcare authorities and reimbursement agencies in the introduction of new drugs.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Control de Medicamentos y Narcóticos
/
Investigación sobre la Eficacia Comparativa
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Ups J Med Sci
Año:
2019
Tipo del documento:
Article
País de afiliación:
Suecia