FDA Issues Guidelines for Using Statistics in Device Trials Speak Now or Forever Hold your Peace

By Daniel R. Matlis 

Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?” What happens if someone objects? Usually there are two outcomes, either the wedding is off or a brawl breaks out.

This is NOT one of those moments, and in this case, I would encourage you to speak your peace.

On May 23, 2006, 2 days after my son was born, The FDA released for comment a Draft Guidance for Industry and FDA Staff on the Use of Bayesian Statistics in Medical Device Clinical Trials.
 

This Guidance is part of the U.S. Food and Drug Administration (FDA) Medical Device Innovation Initiative. This initiative is aimed at making new medical devices available more quickly for patients.

“We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available,” said FDA Acting Commissioner Andrew C. von Eschenbach, M.D. “By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices.” 

The Medical Device Innovation builds on the successes of MDUFMA and further modernizes the medical device review process in order to improve patient health and safety.

As part of this initiative, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials.
In addition, this initiative includes:
 

  • Providing Regulatory Clarity Through Guidance Development
  • Investment in Critical Path
  • Conducting Stakeholder Outreach and Improve Communications
  • Laboratory Research to Support Efforts to Improve the Device Development Process
  • Implementation of a Quality Review Program
  • Leveraging Information Technology Solutions
  • Expanding Clinical and Scientific Expertise at FDA

The comments period expires 90 days from publication in the Federal Register announcing the availability of the draft guidance.

You can submit written comments (usually after checking with Legal and/or Compliance) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You can also submit electronic comments http://www.fda.gov/dockets/ecomments. All comments should be identified with docket number 2006D-0191.

So this is your chance, Speak Now or Forever Hold your Peace.

Well, maybe not forever, but at least until the next guidance document comes along.