An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

Source: Faris O and Shuren J. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials. N Engl J Med. 2017;376:1350-7.DOI: 10.1056/NEJMra1512592

The conduct of clinical trials differs between drugs and devices. Although for some devices, a clinical trial that mimics that of a drug—for example a phase 3 randomized double-blind trial with >1000 participants followed for months or years—may be feasible, but this is not always the case. A review by Faris and Shuren in the March 6, 2017, issue of NEJM describes some alternative approaches that may be used to support the safety and effectiveness of a medical device and achieve marketing approval. Two specific examples put forward are:

1. Use of Modeling and Engineering Tests to Reduce Clinical Trial Requirements
2. Use of Evidence from Clinical Experience

Both examples provide an interesting framework for an innovative trial design that may help to increase the practicality and feasibility for conduct of the trial and reduce the time it would take to provide the evidence needed to achieve marketing approval for a medical device.

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