a Department of Medical Sciences , Uppsala University , Uppsala , Sweden.
b Uppsala Clinical Research Center Uppsala University , Uppsala , Sweden.
Ups J Med Sci. 2019 Jan;124(1):46-50. doi: 10.1080/03009734.2018.1550454. Epub 2019 Jan 28.
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.
为了监测新药的净公共卫生效益，特别是鉴于最近逐步批准的方法，需要利用常规护理中收集的数据来优化新药的实时上市后评估。瑞典拥有独特的观察性研究可能性，可以提供这些数据。我们在此提出了一个使用所有相关利益相关者合作制定的前瞻性协议来持续监测新药的有效性、安全性和成本效益的框架。我们相信，这个框架可以成为医疗保健当局和报销机构在引入新药方面的有用工具。
