By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.
Known as adaptive design, the method can minimize clinical trial sponsors’ resource requirements and increase chances of study success. By spelling out when adaptive designs are acceptable in clinical trials for devices requiring Premarket Approval (PMA) or 510(k) premarket notification, the FDA seeks to better inform both device manufacturers and its own review staff on the benefits and proper implementation of adaptive designs.
The guidance provides several examples of how to properly incorporate adaptive designs into clinical trials, as well as advantages of utilizing such designs: efficiency and cost effectiveness, better understanding of device benefits and risks, and stronger transitions from pre-market analysis to post-market follow-up.
“Overall, adaptive designs may enable more timely device development decision-making and therefore, more efficient investment in resources in a clinical study,” states the FDA guidance.
Meeting clinical study and data requirements can be one of the most costly and challenging issues for manufacturers registering their devices in the US. Through this new guidance, the FDA has demonstrated that adaptive clinical study designs may be one way to offset those challenges for some Class II and III devices undergoing premarket review.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.