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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
Abstract #328583
Title: Active Reference vs. Active Comparator: What Should We Include to Design Late-Phase Studies?
Author(s): Suchitrita Rathmann*
Companies: Eli Lilly & Co
Keywords: active reference; active comparator; phase 3; phase 4; medical affairs; added benefit

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.

Authors who are presenting talks have a * after their name.

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