FDA Finalizes Guidance on Adaptive Designs for Device Studies

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

FDA says it received 151 comments from seven entities, including the Advanced Medical Technology Association (AdvaMed) and AstraZeneca, on the draft guidance and “incorporated most of them in this final guidance.”

Guidance

Adaptive trial designs, first outlined in draft guidance from May 2015, are meant to minimize trial sponsors’ resource requirements and increase the opportunity for success. By spelling out when adaptive designs are acceptable in clinical trials for devices requiring Premarket Approval (PMA) or 510(k) premarket notification, 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.

Among other questions, the guidance seeks to help answer: What adaptive designs are, when to choose one, how to decide if a particular design will be advantageous, as well as details on adaptations using unblinded data, special considerations and challenges for data monitoring committees and institutional review boards.

Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff