Application of Historical Data in Oncology Combination Therapy Development

• Activity Number: 17 - Innovative Statistical Strategies and Designs in Oncology Drug Development
• Type: Topic-Contributed
• Date/Time: Sunday, August 8, 2021 : 1:30 PM to 3:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Rong Liu*
• Companies: Bristol Myers Squibb
• Keywords: Conbination therapy; Historical control borrowing ; oncology drug

Abstract

The presentation will focus on leveraging external information including historical clinical trial data in combination therapy. External control (or synthetic control) is a potential type of control arm in an adequate and well-controlled study as discussed in ICH E10. Recently, this type of control has gained enormous attention in drug development, especially in rare diseases and oncology. Collaborative work on this topic will be shared and discussed.