Active Reference vs. Active Comparator: What Should We Include to Design Late-Phase Studies?

• Activity Number: 542 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
• Type: Roundtables
• Date/Time: Wednesday, August 1, 2018 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Suchitrita Rathmann*
• Companies: Eli Lilly & Co
• Keywords: active reference; active comparator; phase 3; phase 4; medical affairs; added benefit

Abstract

Active comparator studies are becoming increasingly important in the medical affairs world for presenting evidence of added benefit from a new compound introduced in a crowded market with existing therapies for a particular disease. Also, regulatory agencies require phase 3 studies to include a reference arm when other therapies exist in the market. Lack of solid phase 2 evidence and cost limitations often restrict statisticians to design studies that provide head-to-head comparison with an active reference in a phase 3 study design. In this session, we would like to discuss the pros and cons of including a mere reference arm in a phase 3 study as well as the challenges in designing a head-to-head active comparator study in phase 3 or 4.