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

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 t...

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Bibliographic Details
Main Authors: Edmund A. M. Neugebauer, Ana Rath, Sunya-Lee Antoine, Michaela Eikermann, Doerthe Seidel, Carsten Koenen, Esther Jacobs, Dawid Pieper, Martine Laville, Séverine Pitel, Cecilia Martinho, Snezana Djurisic, Jacques Demotes-Mainard, Christine Kubiak, Vittorio Bertele, Janus C. Jakobsen, Silvio Garattini, Christian Gluud
Format: Article
Language:English
Published: BMC 2017-09-01
Series:Trials
Subjects:
Randomised clinical trials
Evidence-based clinical practice
Evidence-based medicine
Assessment
Specific barriers
Medical devices
Online Access:http://link.springer.com/article/10.1186/s13063-017-2168-0

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