Regulatory Experience: Adaptive Designs in CBER Submissions

• Activity Number: 117
• Type: Topic Contributed
• Date/Time: Monday, July 30, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Min Annie Lin*+
• Companies: FDA/CBER
• Keywords: Adaptive Design ; Regulatory Experience

Abstract

The concept of adaptation of trial design during the course of a clinical trial has drawn much interest for development of pharmaceutical products over a decade. When FDA released its draft guidance on adaptive designs in early 2010, we expected sponsors to see a rise in adaptive design protocols in clinical studies, especially for confirmatory trials. Up till now, regulatory experience in these designs is very limited. We recently conducted an internal survey to gather information regarding the regulatory evaluation of adaptive design trial proposals. In this talk, we will present an up-to-date summary of adaptive design practice seen in CBER to provide an overview of regulatory experience. We will share some of the issues and challenges raised during review process. General suggestions from a regulatory view will also be addressed.