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Adaptive Designs for Medical Device Clinical Studies and Other FDA Guidance Releases

Thursday, May 28, 2015   (0 Comments)
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Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff

The FDA posted draft guidance on Adaptive Design for Medical Device Clinical Studies. When finalized, this guidance will provide clarity on the design and use of adaptive designs for clinical studies of medical devices.

Adaptive design allows for planned modifications to a clinical study based on accumulating data, while maintaining the trial’s integrity and validity. When properly implemented, adaptive design can reduce resource requirements and/or increase the chance of study success.

The guidance was issued to encourage companies to consider the use of adaptive design in their clinical trials. It is part of the FDA’s on-going efforts to improve access to new devices by strengthening and streamlining the clinical trial enterprise.

Comments and suggestions regarding this draft guidance can be submitted directly to the FDA. The comment period will be open for 90 days.


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