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A framework for monitoring of new drugs in Sweden.
- Source :
-
Upsala journal of medical sciences [Ups J Med Sci] 2019 Jan; Vol. 124 (1), pp. 46-50. Date of Electronic Publication: 2019 Jan 28. - Publication Year :
- 2019
-
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.
- Subjects :
- Clinical Trials as Topic
Comparative Effectiveness Research economics
Cost-Benefit Analysis
Data Collection
Drug Approval
Drug Industry
Humans
Observational Studies as Topic
Pharmacoepidemiology
Propensity Score
Prospective Studies
Public Health
Sweden epidemiology
Comparative Effectiveness Research methods
Drug and Narcotic Control
Research Design
Subjects
Details
- Language :
- English
- ISSN :
- 2000-1967
- Volume :
- 124
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Upsala journal of medical sciences
- Publication Type :
- Academic Journal
- Accession number :
- 30689485
- Full Text :
- https://doi.org/10.1080/03009734.2018.1550454