Specific barriers to the conduct of randomised clinical trials on medical devices.

ABSTRACT:

Background

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 barriers for randomised clinical trials on medical devices.

Methods

Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN In

SUBMITTER: Neugebauer EAM 

PROVIDER: S-EPMC5597993 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature