Specific barriers to the conduct of randomised clinical trials on medical devices
Abstract
Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the...
Paper Details
Title
Specific barriers to the conduct of randomised clinical trials on medical devices
Published Date
Sep 13, 2017
Journal
Volume
18
Issue
1
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