Building the Evidence Base for Medical Devices: Strategies and Pitfalls
Chapter
Conclusions
There has traditionally been a requirement for efficacy and safety evidence for the licensing of medical devices. devices. However, health-policy makers are increasingly expecting data of the “real world” clinical effectiveness and cost effectiveness of medical devices. and cost effectiveness of medical devices. Furthermore, such data needs to be collected using a randomized controlled trial design. randomized controlled trial design. The collection of such data requires innovative design of medical device clinical trials. clinical trials.
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