Adaptive Design Practice at CDRH, January 2007--May 2013

• Activity Number: 231
• Type: Topic Contributed
• Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Xiting Yang* and Laura Thompson
• Companies: FDA and FDA
• Keywords: Adaptive Design ; Survey ; Medical Device

Abstract

As adaptive designs gain in popularity, they have generated much research interest in the statistical community. Recently, the Center for Devices and Radiological Health (CDRH) at Food and Drug Administration (FDA) summarized the adaptive design applications submitted for regulatory review from 2007 to May 2013. In this talk, we discuss overall results and findings that emerged from in-depth reviews of the submissions. We believe that our summary provides valuable information on the current status of adaptive designs used in medical device studies.