Improvements in Early Phase Innovative Designs Following Sound Regulatory Science

• Activity Number: 429
• Type: Invited
• Date/Time: Wednesday, August 6, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Sue Jane Wang*+
• Companies: FDA

Abstract

In recent decade, early phase trial designs in oncology drug development tend to deviate from conventional fixed designs or simple algorithmic dosing strategies. These designs are, for the most part, adaptive and are often viewed innovative. They are generally different from those early phase trials for non-oncology drug developments, though their common aim is to identify the recommended phase 2 dose. In this talk, I will give a brief overview of early phase trial designs in non-oncology areas. The recent innovative trial designs in oncology drug development will be introduced. Specifically, the results of simulation studies comparing the commonly used 3+3 algorithm-driven approach with an innovative design recently developed will be presented. Further improvement of this method will be illustrated. In addition, other innovative early phase designs will be given. Some modifications to these innovative designs that follow sound regulatory science will be presented. The modifications should improve the practical utilities of these innovative designs resulting in favorable strategies for early phase regulatory consideration.