Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Rosanna Tarricone; Aleksandra Torbica; Francesca Ferré; Mike Drummond

doi:10.1586/14737167.2014.950233

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Rosanna Tarricone, Aleksandra Torbica, Francesca Ferré, Mike Drummond

Centre for Health Economics

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	707-718
Number of pages	12
Journal	Expert Review of Pharmacoeconomics & Outcomes Research
Volume	14
Issue number	5
Early online date	8 Sept 2014
DOIs	https://doi.org/10.1586/14737167.2014.950233
Publication status	Published - Oct 2014

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10.1586/14737167.2014.950233

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title = "Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?",

abstract = "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.",

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