FDA Guidance Emphasizes Randomized, Blinded Trials For PMAs

Article preview from "The Gray Sheet"- August 22, 2011

Clinical studies in support of pre-market approval applications should ideally be randomized and blinded, FDA maintains in recent guidance.

 

FDA Guidance Emphasizes Randomized, Blinded Trials For PMAs

Article preview from "The Gray Sheet"- August 22, 2011

FDA issued draft guidance for sponsors and staff Aug. 15 to help researchers and manufacturers design better-quality clinical trials for device submissions.

“In some cases, issues with clinical trial designs have resulted in poor-quality data, delaying and preventing approval of devices,” Nancy Stade, deputy center director for policy at CDRH, told “The Gray Sheet.”

“FDA believes clearer guidance about the types of design alternatives, and the likelihood that different designs will yield valid scientific evidence, will improve the quality of submissions and increase the likelihood that [investigational device exemptions] and PMAs are approved with fewer cycles of review,” she said.

The draft guidance spells out different clinical study designs that may be appropriate to support device approval, and explains the advantages and disadvantages of each.

But FDA emphasized randomized, blinded (or masked) trials above all else, as other study designs may provide less robust evidence and introduce bias.

Continued...

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