Tarricone Rosanna, Torbica Aleksandra, Ferré Francesca, Drummond Mike
CERGAS (Centre for Research on Health and Social Care Management), Università Bocconi, Via Roentgen, 1 20136 Milan (MI), Italy.
Expert Rev Pharmacoecon Outcomes Res. 2014 Oct;14(5):707-18. doi: 10.1586/14737167.2014.950233. Epub 2014 Sep 8.
Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
通过卫生技术评估来评估卫生技术的价值，严重依赖于有关技术的疗效、安全性以及理想情况下的有效性的相关且可靠的临床数据的存在。然而，就医疗设备而言，由于不同司法管辖区监管要求的性质不同，此类临床数据可能并非总能获取。因此，我们对七个主要司法管辖区的监管要求进行了系统综述，以确定当前面临的挑战并提出可能的改进建议。不同司法管辖区的要求以及上市前和上市后控制之间的平衡存在差异。为了生成用于卫生技术评估的充分临床数据，需要进行若干改进。
