FDA Issues Draft Guidance On Adaptive Design For Device Clinical Studies

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on planning and implementation of adaptive designs for medical device clinical trials.

“An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success,” the FDA stated in a notice posted in the Federal Register.

The guidance document applies to premarket medical device submissions, including premarket approval (PMA) applications, premarket notification (510(k)) submissions, de novo submissions (evaluation of automatic class III designation), humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions. The principles contained in the guidance can be applied throughout a device’s clinical development program, from feasibility studies to clinical trials.

“We are releasing this guidance to further 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by strengthening and streamlining the clinical trial enterprise,” the FDA wrote in an email alert announcing the draft guidance.

According to the guidance, entitled, Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff [PDF], an adaptive design submission to the FDA should clearly identify that a study uses an adaptive design. It should also describe generally in the protocol and in detail in the statistical analysis plan (SAP) — what, when, how, and why adaptations are employed. If a firewall is part of the design, a mechanism and an implementation plan for said firewall should likewise be stated.

“Adaptive clinical study designs for investigational medical devices can improve efficiency and increase the likelihood of study success when conducted in a pre-specified, thoughtful, scientifically valid manner,” the FDA stated in the guidance. “Sponsors are strongly encouraged to discuss the planning of adaptive clinical study designs with the appropriate FDA review division in advance, and the Agency has established mechanisms to conduct such interactions in a timely and efficient manner.”

The guidance belongs to the A-list of priority draft guidance documents for fiscal year 2015 that the FDA announced earlier this year. Written or electronic comments on the adaptive designs for device trials guidance will now be accepted during a 90-day period, or by August 17, 2015.